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 RHEOLYTIC THROMBECTOMY LF140 CATHETER |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S057 |
Date Received | 03/07/2016 |
Decision Date | 04/22/2016 |
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 dual manufacturing site located at Boston Scientific Corporation, 150 Baytech Drive, San Jose, California, for final manufacturing activities, which include incoming inspection, acceptance testing, final packaging, and labeling. |
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