|
Device | AMS 800 ARTIFICAL URINARY SPHINCTER (AUS) |
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 | S023 |
Date Received | 03/09/2009 |
Decision Date | 04/08/2009 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement USE OF AN ALTERNATE FLOW METER TO BE USED DURING THE TESTING OF THE DEVICES¿ CONTROL PUMP AND THE USE OF AN ALTERNATE DISINFECTANT CLEANER FOR SANITIZATION OF THE DEVICE TESTER. |