|
Device | ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S045 |
Date Received | 12/24/2014 |
Decision Date | 03/31/2015 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN INRUSH CURRENT LIMITER TO THE ANGIOJET ULTRA CONSOLE. |