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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, retropubic or transobturator
Definition Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
Product CodeOTN
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATHENA SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CALDERA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 1
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 3
GENERIC MEDICAL DEVICE, INC.
  SUBSTANTIALLY EQUIVALENT 2
GENERIC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MPATHY MEDICAL DEVICES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOMEDIC INTERNATIONAL S.L.
  SUBSTANTIALLY EQUIVALENT 1
UROCURE LLC
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 2050 2050
2015 3900 3900
2016 1900 1900
2017 675 675
2018 737 737
2019 2455 2455
2020 1003 1003
2021 2605 2605
2022 809 809
2023 1076 1076
2024 655 655

Recalls
Manufacturer Recall Class Date Posted
1 American Medical Systems, Inc. II Dec-16-2014
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