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 | REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P130030 |
Supplement Number | S003 |
Date Received | 08/22/2014 |
Decision Date | 09/12/2014 |
Product Code |
MAF |
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 CHANGES TO THE INSPECTION OF INNER SUBASSEMBLIES ON THE STENT DELIVERY CATHETERS. |
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