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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 stress urinary incontinence, female, mini-sling
Regulation Description Surgical mesh.
Definition Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Product CodePAH
Regulation Number 878.3300
Device Class 2


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

Device Problems
Material erosion 254
No Known Device Problem 152
No Information 106
Migration of device or device component 30
Extrusion 16
Break 14
Failure to deploy 4
Other (for use when an appropriate device code cannot be identified) 4
No code available 3
Buckled material 2
Device operates differently than expected 2
Entrapment of device or device component 2
Detachment of device component 1
Premature deployment 1
Slippage of device or device component 1
Unexpected therapeutic results 1
Dislodged or dislocated 1
Deployment issue 1
Detachment of device or device component 1
Tear, rip or hole in device packaging 1
Patient-device incompatibility 1
Loose or intermittent connection 1
Total Device Problems 599

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 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Astora II Nov-16-2015

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