|
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 | S033 |
Date Received | 11/18/2010 |
Decision Date | 12/16/2010 |
Product Code |
EZY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A WARNING STATEMENT IN THE IFU PERTAINING TO THE APPROPRIATE CLEANING METHOD OF REUSABLE TOOLS USED IN THE AMS 800 ARTIFICIAL URINARY SPHINCTER. |