|
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 | S046 |
Date Received | 09/25/2012 |
Decision Date | 11/13/2012 |
Product Code |
EZY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR DESIGN CHANGE TO THE PUMP SHELL INTERFACE TOLERANCES. |