|
Device | AMS 800 ARTIFICAL 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 | S028 |
Date Received | 03/26/2010 |
Decision Date | 04/23/2010 |
Product Code |
EZY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MODIFICATION OF A PARAMETER IN A RECEIVING INSPECTION TEST FOR SILICONE USED IN THE COATING PROCESS. |