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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 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
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 3
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
MPATHY MEDICAL DEVICES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
PROXY BIOMEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material erosion 239
Migration of device or device component 179
No Known Device Problem 145
No code available 35
No Information 28
Other (for use when an appropriate device code cannot be identified) 21
Defective item 2
Extrusion 2
Torn material 1
Incomplete or missing packaging 1
Unsealed device packaging 1
Total Device Problems 654

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Coloplast Manufacturing US, LLC II May-20-2013

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