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Device | PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN |
Generic Name | Device, incontinence, mechanical/hydraulic |
Regulation Number | 876.5280 |
Applicant | UROMEDICA INC 1840 BERKSHIRE LANE N PLYMOUTH, MN 55441 |
PMA Number | P130018 |
Date Received | 06/17/2013 |
Decision Date | 11/24/2015 |
Product Code |
EZY |
Docket Number | 15M-4473 |
Notice Date | 02/27/2017 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT00277095
|
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 |