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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
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 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 1244
Material erosion 748
No Information 203
Detachment of device component 130
Migration of device or device component 107
Extrusion 78
Break 45
No code available 23
Retraction problem 10
Other (for use when an appropriate device code cannot be identified) 7
Malposition of device 3
Material separation 2
Degraded 2
Material Protrusion 2
Torn material 1
Unintended movement 1
Disconnection 1
Fire 1
Material frayed 1
Mechanical issue 1
Folded 1
Device operates differently than expected 1
Material deformation 1
Tear, rip or hole in device packaging 1
High test results 1
Misfire 1
Total Device Problems 2616

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