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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
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 CodePAH
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
MPATHY MEDICAL DEVICES, LTD.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 18
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 19

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