510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PAHClass II

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

21 CFR 878.3300 / General, Plastic Surgery
FDA source (opens on fda.gov)

PAH is the FDA product code for Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility". As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PAH
Device name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
FDA definition
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
20
Ingested recalls
1

Clearances, product code PAH

By decision year
20 clearances under product code PAH with a decision year between 2002 and 2024, 2012 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code PAH by decision year
YearClearances
20021
20031
20051
20061
20072
20083
20092
20101
20111
20124
20201
20231
20241

Applicants with the most clearances

Product code PAH
Applicants holding the most 510(k) clearances under product code PAH
ApplicantClearances
American Medical Systems, Inc.5
MEDLINE INDUSTRIES, LP - Northfield3
C.R. Bard Inc2
Caldera Medical, Inc.2
Mpathy Medical Devices, Ltd.2
Boston Scientific Corporation1
Ethicon, Inc1
Gyne Ideas, Ltd.1
Herniamesh SRL1
Promedon1

Companies listing this code with FDA

Companies whose registered establishments list this code