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

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

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

PAG is the FDA product code for Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, 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 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PAG
Device name
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
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
9
Ingested recalls
0

Clearances, product code PAG

By decision year
9 clearances under product code PAG with a decision year between 1998 and 2009, 1999 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PAG by decision year
YearClearances
19981
19992
20021
20032
20041
20051
20091

Applicants with the most clearances

Product code PAG
Applicants holding the most 510(k) clearances under product code PAG
ApplicantClearances
Cook Biotech, Inc.3
Brennen Medical, Inc.2
C.R. Bard Inc2
Advanced Uroscience, Inc.1
American Medical Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code