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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrumentation, surgical mesh, urogynecologic, stress urinary incontinence
Definition Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence
Product CodePWJ
Regulation Number 884.4910
Device Class 2


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

MDR Year MDR Reports MDR Events
2018 1 1
2019 1 1
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Improper or Incorrect Procedure or Method 1 1
Patient-Device Incompatibility 1 1
Material Twisted/Bent 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 2 2
Pain 2 2
Urinary Frequency 1 1
Malaise 1 1
Bowel Perforation 1 1
Dyspareunia 1 1
Insufficient Information 1 1
Nerve Damage 1 1
Abscess 1 1
Fever 1 1

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