|
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 | S041 |
Date Received | 03/07/2012 |
Decision Date | 08/21/2012 |
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 REVISION OF THE AMOUNT OF RIFAMPIN AND MINOCYCLINE SPECIFIED IN THE INSTRUCTION FOR USE AND THE OPERATING ROOM MANUAL. |