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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 1190
Material erosion 697
No Information 184
Migration of device or device component 96
Detachment of device component 87
Extrusion 67
Break 32
No code available 17
Retraction problem 10
Other (for use when an appropriate device code cannot be identified) 5
Malposition of device 2
Material separation 2
Degraded 2
Material Protrusion 2
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 2404

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