|
Device | Wolverine Coronary Cutting Balloon (Monorail) |
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 | S076 |
Date Received | 11/02/2016 |
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 Manufacturing changes to the Distal Outer extrusion process and subsequent changes to the Distal Outer component specifications. |