|
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 | S050 |
Date Received | 10/01/2015 |
Decision Date | 11/02/2015 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED IN FREMONT, CALIFORNIA FOR FINISHED DEVICE RELEASE TEST, PACKAGING AND LABELING. |