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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
Regulation Description Surgical mesh.
Definition Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
Product CodeOTO
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CALDERA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Adverse Event Without Identified Device or Use Problem 460
Migration or Expulsion of Device 182
Insufficient Information 68
Appropriate Term/Code Not Available 59
Migration 56
Other (for use when an appropriate device code cannot be identified) 20
Material Erosion 13
Break 9
Torn Material 9
Patient-Device Incompatibility 8
Material Split, Cut or Torn 7
Device Appears to Trigger Rejection 6
Detachment of Device or device Component 3
Extrusion 2
Unsealed Device Packaging 2
Material Deformation 2
Mechanical Problem 2
Defective Device 2
Material Twisted / Bent 1
Material Too Rigid or Stiff 1
Material Protrusion / Extrusion 1
Explanted 1
Nonstandard device 1
Degraded 1
No Apparent Adverse Event 1
Material Frayed 1
Stretched 1
Total Device Problems 919


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