|
Device | AMS 800 URINARY CONTROL SYSTEM |
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 | S045 |
Date Received | 09/10/2012 |
Decision Date | 10/05/2012 |
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 THE SILICON RECEIVING INSPECTION AND MILLING PROCESSES TO BE STREAMLINED AND TO REMOVE DUPLICATE TESTING TO PROVIDE CONSISTENCY FOR THE ENTIRE SILICONE PROCESSES. |