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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 146
No Information 96
Migration of device or device component 27
Break 14
Extrusion 14
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
Failure to deploy 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
Patient-device incompatibility 1
Loose or intermittent connection 1
Total Device Problems 575

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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