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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse
Regulation Description Specialized surgical instrumentation for use with urogynecologic surgical mesh.
Definition Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair
Product CodePWI
Regulation Number 884.4910
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 4
Insufficient Information 1
Total Device Problems 5

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II May-04-2018

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