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 | CORONARY FLEXTOME CUTTING BALLOON |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P950020 |
Supplement Number | S047 |
Date Received | 11/04/2011 |
Decision Date | 12/07/2011 |
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 CHANGE TO THE MANUFACTURING PROCESS EQUIPMENT BY IMPLEMENTING AN ALTERNATE BIOSLIDE COATING MACHINE, WITH UPDATED HARDWARE, SOFTWARE, AND PROCESSING CHANGES, AS WELL AS A MINOR REARRANGEMENT OF THE EXISTING PRODUCTION EQUIPMENT TO NEW LOCATIONS WITHIN THE CURRENT MANUFACTURING LINE. |
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