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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, incontinence, mechanical/hydraulic
Regulation Description Implanted mechanical/hydraulic urinary continence device.
Definition PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00))
Product CodeEZY
Regulation Number 876.5280
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025 2026
10 3 6 4 3 6 3

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Nov-25-2024
2 Uromedica Inc. II Jan-05-2022
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