|
Device | AMS SPHINCTER 800 URINARY PROSTHESIS |
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 | S037 |
Date Received | 06/09/2011 |
Decision Date | 06/24/2011 |
Product Code |
EZY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATIONS AND MANUFACTURING PROCESS OF THE AMS 800 CONTROL PUMP, A COMPONENT OF THE AMS SPHINCTER 800 URINARY PROSTHESIS. |