|
Device | WOLVERINE CORONARY CUTTING BALLOON MONORAIL (MR) AND OVER-THE WIRE (OTW) |
Generic Name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P950020 |
Supplement Number | S077 |
Date Received | 11/17/2016 |
Decision Date | 12/01/2016 |
Product Code |
NWX |
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 Addition of an alternative supplier for the atherotome microsurgical blades used on the WOLVERINE Coronary Cutting Balloon. |