|
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 | S013 |
Date Received | 10/09/2007 |
Decision Date | 11/05/2007 |
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 IMPLEMENTATION OF ADDITIONAL PRESS EQUIPMENT FOR MOLD MANUFACTURING OF THE AMS 800 ARTIFICIAL URINARY SPHINCTER. |