|
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 | S040 |
Date Received | 01/18/2012 |
Decision Date | 03/09/2012 |
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 | Yes |
Approval Order Statement APPROVAL FOR MINOR CHANGES TO SEVERAL DIMENSIONAL TOLERANCES OF THE BALLOON ADAPTOR SUBCOMPONENT. |