|
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 |
Supplement Number | S001 |
Date Received | 12/21/2015 |
Decision Date | 11/02/2016 |
Product Code |
EZY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the protocol for the post-approval study protocol. |