Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ANGIOJET ULTRA XMI THROMBECTOMY SET, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMOBECTOMY SET |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S051 |
Date Received | 11/05/2015 |
Decision Date | 12/02/2015 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement TO ESTABLISH AN ALTERNATE VENDOR, BOSTON SCIENTIFIC CORPORATION MAPLE GROVE, FOR THE PUMP SUB-ASSEMBLY COMPONENT OF THE ANGIOJET ULTRA THROMBECTOMY SYSTEM. |
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