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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 pelvic organ prolapse, transvaginally placed
Regulation Description Surgical mesh for transvaginal pelvic organ prolapse repair.
Definition Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical and uterine prolapse repair completed transvaginally.
Product CodePAI
Regulation Number 884.5980
Device Class 3


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
TISSUE SCIENCE LABORATORIES, PLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 26
No Information 5
Extrusion 1
Total Device Problems 32

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