American Medical Systems, Inc.
Minnetonka, MN, US
American Medical Systems, Inc. appears in FDA device records in Minnetonka, MN. FDA records list 82 510(k) clearances between and , 3 PMA records and no registered establishments. As of , FDA records show 24 recalls for this company.
FDA records held for this company
510(k) clearance history
Showing 50 of 82FDA records hold 82 510(k) clearances for American Medical Systems, Inc. between 1979 and 2014. The busiest year on record is 2008, with 9. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 1 |
| 1982 | 4 |
| 1983 | 2 |
| 1984 | 1 |
| 1985 | 1 |
| 1988 | 1 |
| 1990 | 4 |
| 1992 | 6 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 3 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 7 |
| 2002 | 4 |
| 2003 | 2 |
| 2004 | 6 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 4 |
| 2008 | 9 |
| 2009 | 4 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 4 |
| 2013 | 2 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140679 | SUREFLEX LITHOTRIPSY LASER FIBERS | GEX | Substantially Equivalent | |
| K131229 | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS | OTN | Substantially Equivalent | |
| K132655 | RETROARC RETROPUBIC SLING SYSTEM | OTN | Substantially Equivalent | |
| K121805 | AMS LARGE PORE POLYPROPHLENE MESH | OTO | Substantially Equivalent | |
| K121641 | MINIARC PRO SINGLE-INCISION SLING SYSTEM | PAH | Substantially Equivalent | |
| K121612 | ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION | OTP | Substantially Equivalent | |
| K120870 | GREENLIGHT MOXY FIBER OPTIC | GEX | Substantially Equivalent | |
| K112842 | AMS ELEVATE PC | OTP | Substantially Equivalent | |
| K111118 | AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | OTP | Substantially Equivalent | |
| K100746 | FIBER ONE | GEX | Substantially Equivalent | |
| K100807 | MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 | PAH | Substantially Equivalent | |
| K092735 | GREENLIGHT XPS LASER SYSTEM | GEX | Substantially Equivalent | |
| K090934 | PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM | FTL | Substantially Equivalent | |
| K090663 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | FAE | Substantially Equivalent | |
| K090713 | ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP | OTP | Substantially Equivalent | |
| K082677 | AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | OTP | Substantially Equivalent | |
| K082387 | APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM | OTP | Substantially Equivalent | |
| K082730 | AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE | OTP | Substantially Equivalent | |
| K082006 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | FAE | Substantially Equivalent | |
| K081710 | APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE | OTP | Substantially Equivalent | |
| K081613 | SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS | OTN | Substantially Equivalent | |
| K080185 | AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM | OTP | Substantially Equivalent | |
| K073219 | WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 | FTM | Substantially Equivalent | |
| K073703 | AMS MINIARC SLING SYSTEM | PAH | Substantially Equivalent | |
| K071902 | AMS MINIARC SLING SYSTEM | PAH | Substantially Equivalent | |
| K070993 | TOPAS SYSTEM | FTL | Substantially Equivalent | |
| K070065 | AMS SINGLE INCISION SLING SYSTEM (SIS-0) | PAH | Substantially Equivalent | |
| K063713 | AMS SMART SLING SYSTEM | OTN | Substantially Equivalent | |
| K053371 | AMS MALE TRANSOBTURATOR SLING SYSTEM | OTM | Substantially Equivalent | |
| K051485 | AMS PELVIC FLOOR REPAIR SYSTEM | OTO | Substantially Equivalent | |
| K051530 | MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. | OTN | Substantially Equivalent | |
| K050445 | AMS COLLAGEN DERMAL MATRIX | PAG | Substantially Equivalent | |
| K042592 | INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304 | OTN | Substantially Equivalent | |
| K041948 | SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS | OTN | Substantially Equivalent | |
| K040623 | AMS PERIGEE SYSTEM | OTP | Substantially Equivalent | |
| K040537 | AMS APOGEE VAULT SUSPENSION SYSTEM | OTP | Substantially Equivalent | |
| K040521 | MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH | OTP | Substantially Equivalent | |
| K040538 | BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996 | OTN | Substantially Equivalent | |
| K033636 | AMS LARGE PORE POLYPROPYLENE MESH | OTP | Substantially Equivalent | |
| K030123 | BIOARC SP SLING KIT | OTN | Substantially Equivalent | |
| K023516 | MONARC SLING SYSTEM | OTN | Substantially Equivalent | |
| K021263 | MODIFICATION TO SPARC SLING SYSTEM | OTN | Substantially Equivalent | |
| K020663 | MODIFICATION TO SPARC SLING SYSTEM | OTN | Substantially Equivalent | |
| K020446 | MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM | HWC | Substantially Equivalent | |
| K013355 | SPARC SLING SYSTEM | OTN | Substantially Equivalent | |
| K012342 | AMS SOFT-TISSUE APPROXIMATION SYSTEM | FZP | Substantially Equivalent | |
| K011251 | SPARC SLING SYSTEM | OTN | Substantially Equivalent | |
| K011910 | IN-FAST BONE SCREW SYSTEM | HWC | Substantially Equivalent | |
| K010990 | AMS SLING FIXATION SYSTEM | GAW | Substantially Equivalent | |
| K010931 | AMS SACRAL COLPOPEXY SLING, MODEL 72403501 | OTO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- NEHAnchor, Fascial
- GBMCatheter, Urethral
- FZPClip, Implantable
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device
- EZNDilator, Catheter, Ureteral
- KOEDilator, Urethral
- FFLDislodger, Stone, Basket, Ureteral, Metal
- FASElectrode, Electrosurgical, Active, Urological
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- FHNLigator, Hemorrhoidal
- KMJLubricant, Patient
- FTMMesh, Surgical
- OTMMesh, Surgical, For Stress Urinary Incontinence, Male
- PAGMesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- FTLMesh, Surgical, Polymeric
- OTOMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
- PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
- OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- GEXPowered Laser Surgical Instrument
- FAEProsthesis, Penile
- FAGProsthesis, Urethral Sphincter
- HWCScrew, Fixation, Bone
- FADStent, Ureteral
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- MVFSystem, Laser, Photodynamic Therapy
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DWJSystem, Thermal Regulating
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0806-2015 | AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance Male Sling System consists of two, sterile single-use surgical instruments called helical needle passers and a mesh sling with attached connectors. One end of each helical needle passer is keyed to allow a secure attachment of the sling connectors. The sling mesh is constructed of polypropylene monofilament mesh that is precut to 1.2 centimeters arm width, 3.55 centimeters center width, and 35.5 centimeters length. Two absorbable tensioning sutures are threaded into the length of the mesh. Plastic sheaths are placed over each arm of the mesh to aide in ease of placement. The connectors are attached to the ends of the helical needle passers during the procedure. The mesh and suture portions of the sling are intended to remain in the body as a permanent implant and the mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes. | During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sling System; Model # 720088-01; AdVance" XP Male Sling System; Model # 720163-01; Monarc" C Subfacial Hammock; Model # 72404195; Monarc" + Subfacial Hammock; Model # | Class II | Terminated | |
| Z-0805-2015 | AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting of two stainless steel, curved needle passers. The tip portion of each needle passer is configured to allow for secure placement of the connectors. Each needle passer has a plastic handle attached. The system also contains a sling assembly including one piece of loosely knitted polypropylene mesh, two removable plastic insertion sheaths attached to the mesh, and two connectors attached to the insertion sheaths. The mesh is constructed of polypropylene monofilament. An absorbable tensioning suture is threaded into the length of the mesh to allow for tensioning adjustment of the mesh after placement in the patient is achieved. The plastic covering also affords convenient travel of the mesh through the tissue. The connectors are attached to the tip portions of the Monarc needle passers during the procedure. The loosely knitted polypropylene mesh is intended to remain in the body as a permanent implant. The mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes. | During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sling System; Model # 720088-01; AdVance" XP Male Sling System; Model # 720163-01; Monarc" C Subfacial Hammock; Model # 72404195; Monarc" + Subfacial Hammock; Model # | Class II | Terminated | |
| Z-0209-2015 | AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa. | AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool. | Class II | Terminated | |
| Z-1280-2013 | AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck. | American Medical Systems, Inc. is initiating a recall on two components of the AMS 800 Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria. | Class II | Terminated | |
| Z-1279-2013 | AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck. | American Medical Systems, Inc. is initiating a recall on two components of the AMS 800 Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria. | Class II | Terminated | |
| Z-0259-2013 | AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI). | American Medical Systems (AMS) is issuing a voluntary recall on a number of lots of the AdVance Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product. An internal investigation has been conducted and confirmed that some sutures degraded prior to the | Class II | Terminated | |
| Z-2755-2011 | Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System, REF720093-01, Sterile EO, Manufactured by:American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA Product Usage: The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenteriological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair. As configured, the Elevate Anterior device is used solely for prolapse repair | This is an important notification regarding the Elevate Anterior and Apical Prolapse Repair Systems, Part Number 720093-01, manufactured between August 3, 2010 and January 17, 2011. We have recently received complaints stating that the eyelets were missing from the center graft of some units within the scope of this issue. The complaint rate to-date for the affected product is 0.045%, however th | Terminated | ||
| Z-2669-2011 | AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343 InhibiZone Antibiotic Surface Treatment, AMS 800 Urinary Control Pump with InhibiZone, REF 72404127, Sterilization Method ETO, American Medical Systems Inc., 10700 Bren West, Minnetonka, MN 55343 The AMS Urinary Control System (of which the pump is a component) is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. | American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we are unable to confirm that all Control Pumps have met our requirements. Test errors could potentially result in a failure to identify a malfunction in the Control Pump activation mechanism. This malfunction may lead to inadvertent activa | Terminated | ||
| Z-2668-2011 | AMS Acticon Neosphincter Pump, Product Number 72402287, Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343. The Acticon Neosphincter is an implantable device used to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for less invasive forms of restorative therapy. | American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we are unable to confirm that all Control Pumps have met our requirements. Test errors could potentially result in a failure to identify a malfunction in the Control Pump activation mechanism. This malfunction may lead to inadvertent activa | Terminated | ||
| Z-0808-2011 | Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL; Model # 72404224: Male TO Sling System, INTL. Sterilization Method ETO, American Medical systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA | American Medical Systems (AMS) is recalling all lots of the AdVance male Sling System with an expiration date between July 2012 and August 2013. Internal testing has indicated the potential for degradation of the bioabsorbable tensioning sutures when the product is stored for longer than 15 months after the date of manufacture. | Terminated | ||
| Z-0932-2009 | AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile non-perforated processed porcine collagen dermal matrix. Sterile EO. American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The AMS collagen dermal matric is intended for use in the treatment of hernias where connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, or gastroenterological anatomy. | The product size shown on the carton labeling does not match the size on the product inside. | Terminated | ||
| Z-2461-2008 | AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232, Lot 551668001. Expiration Date 2010-Jun-20, Manufacture Date 2008 Jun 20. | The carton labeling does not match the product packaged inside. The package indicated that the device is an 18cm Preconnected MS pump while it is actually an 18cm Ultrex Preconnected MS Pump. | Terminated | ||
| Z-1235-2008 | AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System. | Missing part: The units in two lots of In-Fast Ultra Transvaginal Bladder Neck Support System may contain only one bone screw, but should contain two as indicated on the labeling. Two screws are required to complete the procedure. The missing screw will result in the inability to complete the procedure as expected if there are no additional screws readily available. | Terminated | ||
| Z-0703-2007 | AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN | Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels. | Terminated | ||
| Z-0702-2007 | AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN | Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels. | Terminated | ||
| Z-0789-2007 | AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm, product number 72404251. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders. | The carton labeling does not match the product packaged inside. | Terminated | ||
| Z-0788-2007 | AMS 700 CX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm product number 72404231. Penoscrotal Approach - with InhibiZone, 1 Pump, 2 Cylinders. | The carton labeling does not match the product packaged inside. | Terminated | ||
| Z-0787-2007 | AMS 700 CX Preconnected penile Prosthesis with InhibiZone, product length 18 cm, product number 72402987. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Pump, 2 Cylinders. | The carton labeling does not match the product packaged inside. | Terminated | ||
| Z-0786-2007 | AMS 700 CX MS Pump IZ Preconnected penile Prosthesis, product length 18 cm, product number 72404232. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders. | The carton labeling does not match the product packaged inside. | Terminated | ||
| Z-0785-2007 | AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, product number 72403924. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Tactile Pump, 2 Cylinders. | The carton labeling does not match the product packaged inside. | Terminated | ||
| Z-0675-06 | her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe. | Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances. | Terminated | ||
| Z-0931-04 | AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451 | The product is mislabeled as to length. | Terminated | ||
| Z-0930-04 | AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450 | The product is mislabeled as to length. | Terminated | ||
| Z-1019-04 | Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1 | Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain