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 | Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S191 |
Date Received | 10/22/2020 |
Decision Date | 11/23/2020 |
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 at 4100 Hamline Avenue North, St. Paul, Minnesota, 55112 for the manufacture, repair, distribution and warehousing activities for the Rotablator and ROTAPRO Consoles. |
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