|
Device | FLEXTOME CORONARY CUTTING BALLOON |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P950020 |
Supplement Number | S061 |
Date Received | 03/29/2013 |
Decision Date | 06/21/2013 |
Product Codes |
MAF NIN NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MANUFACTURE THE FLUSHING NEEDLE (ALSO KNOWN AS TIP BARRELL 30 GAUGE) ACCESSORY WITH AN ALTERNATIVE RESIN PROVIDED BY A NEW SUPPLIER. |