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 | FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P950020 |
Supplement Number | S021 |
Date Received | 11/07/2006 |
Decision Date | 12/06/2006 |
Product Code |
LOX |
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 USE OF A CARBOLITE OVEN IN THE LETTERKENNY, IRELAND FACILITY TO CURE THE MDX COATING ON BALLOON FOLDERS. |
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