|
Device | AMS 800 ARTIFICIAL URINARY SPHINCTER |
Generic Name | Device, incontinence, mechanical/hydraulic |
Regulation Number | 876.5280 |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P000053 |
Supplement Number | S050 |
Date Received | 01/10/2014 |
Decision Date | 06/16/2014 |
Product Code |
EZY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE PHYSICIAN LABELING TO SUMMARIZE THE RESULTS OF THE INHIBIZONE POST-APPROVAL STUDY |