PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
FDA premarket approval P130018 · decided 2015-11-24
Approval details
- PMA number
- P130018
- Trade name
- PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
- Generic name
- Device, incontinence, mechanical/hydraulic
- Applicant
- Uromedica, Inc.
- Date received
- 2013-06-17
- Decision date
- 2015-11-24
- Days to decision
- 890 days
- Decision code
- APPR
- Product code
- EZY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN. THIS DEVICE IS INDICATED FOR THE TREATMENT OF ADULT MEN WHO HAVE STRESS INCONTINENCE ARISING FROM INTRINSIC SPHINCTER DEFICIENCY OF AT LEAST TWELVE MONTHS DURATION FOLLOWING RADICAL PROSTATECTOMY OR TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) AND WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE THERAPY.
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