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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Regulation Description Surgical mesh.
Definition Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Product CodePAG
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 41
No Information 12
Device operates differently than expected 1
Total Device Problems 54

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