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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 268
No Known Device Problem 188
No Information 107
Migration of device or device component 32
Break 17
Extrusion 16
No code available 12
Failure to deploy 12
Bent 7
Other (for use when an appropriate device code cannot be identified) 5
Detachment of device component 3
Entrapment of device or device component 2
Buckled material 2
Device operates differently than expected 2
Device packaging compromised 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
Premature deployment 1
Slippage of device or device component 1
Unexpected therapeutic results 1
Material deformation 1
Total Device Problems 684

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 0 0
Class III 0 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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