PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
FDA premarket approval P130018/S001 · decided 2016-11-02
Approval details
- PMA number
- P130018
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
- Generic name
- Device, incontinence, mechanical/hydraulic
- Applicant
- Uromedica, Inc.
- Date received
- 2015-12-21
- Decision date
- 2016-11-02
- Days to decision
- 317 days
- Decision code
- APPR
- Product code
- EZY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval of the protocol for the post-approval study protocol.
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