Ela Medical, Inc.
Plymouth, MN, US
Ela Medical, Inc. appears in FDA device records in Plymouth, MN. FDA records list 43 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 11 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 43 510(k) clearances for Ela Medical, Inc. between 1979 and 2004. The busiest year on record is 1988, with 5. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 4 |
| 1980 | 2 |
| 1981 | 4 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1985 | 3 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 5 |
| 1989 | 4 |
| 1990 | 3 |
| 1995 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042002 | SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER | DQK | Substantially Equivalent | |
| K032466 | SPIDERVIEW | MWJ | Substantially Equivalent | |
| K002817 | SYNETEC | DQK | Substantially Equivalent | |
| K993448 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | DTB | Substantially Equivalent - Subject to Tracking Reg. | |
| K000029 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | DTB | Substantially Equivalent | |
| K990727 | SYNEFLASH & SYNEVIEW | DQK | Substantially Equivalent | |
| K972574 | STELA MODEL UJ45 PACING LEADS | DTB | Substantially Equivalent - Subject to Tracking Reg. | |
| K970072 | OPUS S MODEL 4121 AND 4124 PACEMAKERS | DXY | Substantially Equivalent - Subject to Tracking Reg. | |
| K963738 | STELA MODEL BJ44 AND BJ45 PACING LEADS | DTB | Substantially Equivalent - Subject to Tracking & PMS | |
| K952364 | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) | DXY | Substantially Equivalent - Subject to Tracking Reg. | |
| K952363 | OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) | ELA | Substantially Equivalent | |
| K896742 | FOCUS J81F, J83F, J41F, J43F PACING LEADS | DTB | Substantially Equivalent | |
| K895806 | ELATEC HOLTER ANALYZER | DSI | Substantially Equivalent | |
| K900461 | OPUS MODEL 4021, VVI, 5MM UNIPOLAR | DXY | Substantially Equivalent | |
| K894065 | OPUS MODEL 4001 | DXY | Substantially Equivalent | |
| K894267 | OPUS MODELS 4033 AND 4034 | DXY | Substantially Equivalent | |
| K890018 | PACEMAKER LEAD ADAPTER | DTB | Substantially Equivalent | |
| K883037 | UNILITH 3 MODELS 7580/7583/7680/7683 | DXY | Substantially Equivalent | |
| K884394 | PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F | DTB | Substantially Equivalent | |
| K882391 | OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024 | DXY | Substantially Equivalent | |
| K882427 | CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 | DXY | Substantially Equivalent | |
| K882476 | OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004 | DXY | Substantially Equivalent | |
| K882474 | OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004 | DXY | Substantially Equivalent | |
| K872731 | PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860 | DTB | Substantially Equivalent | |
| K863898 | MULTILITH 3 MODELS 1350, 3350, 1370, 3370 | DXY | Substantially Equivalent | |
| K852973 | UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 | DXY | Substantially Equivalent | |
| K851731 | ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860 | DTB | Substantially Equivalent | |
| K853017 | ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 | DXY | Substantially Equivalent | |
| K842193 | MULTILITH PULSE GENERATORS, 1141 & 2141 | DXY | Substantially Equivalent | |
| K842220 | MULTILITH 2 PULSE GENERATOR 1141 & 2141 | DXY | Substantially Equivalent | |
| K830457 | PACING LEAD #PMA F 860 | DTB | Substantially Equivalent | |
| K830401 | UNILITH PULSE GENERATOR VVI #7542 | DXY | Substantially Equivalent | |
| K813246 | MEDICAL MULTILITH PULSE GENERA-1140 | DXY | Substantially Equivalent | |
| K810887 | ELA MEDICAL UNILITH 7540 PULSE GENERATOR | DXY | Substantially Equivalent | |
| K810489 | MULTILITH PULSE GENERATOR #1140 | DXY | Substantially Equivalent | |
| K810142 | ELA MEDICAL UNILITH PULSE GENERATOR | DXY | Substantially Equivalent | |
| K810626 | ELA MEDICAL PACING LEAD MODEL PMA 860 | Unknown | ||
| K792602 | SUSI II PACEMAKER SURVEILLANCE MONITOR | DTC | Substantially Equivalent | |
| K791975 | PACING SYSTEM ANALYZER PSA SCE-22 | DTC | Substantially Equivalent | |
| K792239 | ELA MEDICAL ANATEC HOLTER SCANNER | Unknown | ||
| K791219 | UNILITH PULSE GENERATOR | DXY | Substantially Equivalent | |
| K790562 | PULSE GENERATOR MODEL 61 AND 128 | DXY | Substantially Equivalent | |
| K790386 | LEAD MODELS MUM 1260, MUM 1290 | DTB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2609-2011 | Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino s.n., 13040 Saluggia(VC) Italy PARADYM DR 8550 and PARADYM VR 8250 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent, poorly tolerated sustained ventricular tachycardia (VT). | On February 28, 2011, the company discovered that since the beginning of the US commercial distribution of Paradym DR 8550 and Paradym VR 8250 ICDs in October 2010, the devices included an incorrect version of the Patient Booklet. The company determined that there is no risk of adverse event associated with this labeling error. | Terminated | ||
| Z-2579-2010 | Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy | The Paradym CRT 8750 and CRT sonR 8770 device models have a software anomaly, which will cause the device to lose the ability to sense/pace and to deliver further therapy. The software anomaly could only occurs under a specific sequence of events. | Terminated | ||
| Z-2235-2009 | Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescentino s.n., 13040 Saluggia (VC) Italy. ELA Medical, Inc., 14401 West 65th Way, Arvada, CO 80004, USA. REPLY DR is a DDDR-type dual-chamber rate-responsive pacemaker. It is equipped with a physiological sensor and an accelerometer to allow adaptation of pacing to suit the patient's activity. The REPLY device can be programmed to separate pacing and sensing polarities, independent of chamber. | Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew. | Terminated | ||
| Z-0267-06 | ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France. | Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process. | Terminated | ||
| Z-0266-06 | Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France. | Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process. | Terminated | ||
| Z-1598-05 | Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ventricular antitachycardia pacing. Dual chamber arrhythmia detection. biventricular pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies. | Devices manufactured prior to August 2004 may experience premature battery depletion and/or extended charge times which may affect the device's ability to function. | Terminated | ||
| Z-1597-05 | Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Single chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies. | Devices manufactured prior to August 2004 may experience premature battery depletion and/or extended charge times which may affect the device's ability to function. | Terminated | ||
| Z-1587-05 | Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Dual chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies. | Devices manufactured prior to August 2004 may experience premature battery depletion and/or extended charge times which may affect the device's ability to function. | Terminated | ||
| Z-0802-05 | Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support. | A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750V charge times and disable the device's ability to report an End of Life (EOL) indicator due to excessive charge times unless the patient is receiving periodic 750V therapy shocks. | Terminated | ||
| Z-0801-05 | Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support. | A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750V charge times and disable the device's ability to report an End of Life (EOL) indicator due to excessive charge times unless the patient is receiving periodic 750V therapy shocks. | Terminated | ||
| Z-0176-05 | Alto implantable cardioverter defibrillator | Alto Implantable Defibrillators Models 614 and 615. These models can experience sudden no output, and early end of life characteristics due to metal migration in their controlling hybrids, causing high current drain leading to premature battery depletion. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain