|
Device | SPHINCTER 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 | S005 |
Date Received | 01/04/2005 |
Decision Date | 10/13/2006 |
Product Code |
EZY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE ADDITION OF INHIBIZONE TREATMENT TO COMPONENTS OF THE SPHINCTER 800 URINARY CONTROL SYSTEM, SPECIFICALLY THE CUFFS, PUMPS, AND KINK RESISTANT TUBING. |
Post-Approval Study | Show Report Schedule and Study Progress |