ProACT Adjustable Continence Therapy for Men
FDA premarket approval P130018/S003 · decided 2025-05-20
Approval details
- PMA number
- P130018
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ProACT Adjustable Continence Therapy for Men
- Generic name
- Device, incontinence, mechanical/hydraulic
- Applicant
- Uromedica, Inc.
- Date received
- 2025-04-07
- Decision date
- 2025-05-20
- Days to decision
- 43 days
- Decision code
- OK30
- Product code
- EZY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- addition of an alternate gamma radiation cell
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