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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 pelvic organ prolapse, transvaginally placed
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 or uterine prolapse repair performed transvaginally
Product CodeOTP
Regulation Number 884.5980
Device Class 3


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 13
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 2
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 1185
Material erosion 697
No Information 182
Migration of device or device component 95
Detachment of device component 74
Extrusion 65
Break 18
No code available 17
Retraction problem 8
Other (for use when an appropriate device code cannot be identified) 5
Material Protrusion 2
Material separation 2
Disconnection 1
Fire 1
Material frayed 1
Mechanical issue 1
Material deformation 1
High test results 1
Misfire 1
Folded 1
Device operates differently than expected 1
Unintended movement 1
Total Device Problems 2360

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