|
Device | ANGIOJET ULTRA THROMBECTOMY SYSTEM |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S014 |
Date Received | 08/01/2005 |
Decision Date | 12/07/2006 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A REDESIGN OF THE DRIVE UNIT (ULTRA CONSOLE) AND TO COMBINE THE PUMP SET AND CATHETERS INTO A SINGLE THROMBECTOMY SET (WITH DIFFERENT MODELS CORRESPONDING TO THE CURRENT XMI AND XMI-RX CATHETER MODELS). |