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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.
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 878.3300
Device Class 2


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

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