ProACT Adjustable Continence Therapy for Men
FDA premarket approval P130018/S004 · decided 2025-10-03
Approval details
- PMA number
- P130018
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ProACT Adjustable Continence Therapy for Men
- Generic name
- Device, incontinence, mechanical/hydraulic
- Applicant
- Uromedica, Inc.
- Date received
- 2025-09-03
- Decision date
- 2025-10-03
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- EZY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval of the modifications to the study protocol including expansion of the study to 10-14 study sites and modifications to the Informed Consent Form for the post-approval study.
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