|
Device | Wolverine Coronary Cutting Balloon |
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 | S087 |
Date Received | 10/17/2017 |
Decision Date | 11/16/2017 |
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 Use of the optimized BSC2000-2 EO sterilization cycle in Chambers 8 and 9 at Synergy Health Tullamore. |