|
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 | S112 |
Date Received | 08/04/2021 |
Decision Date | 11/02/2021 |
Product Code |
NWX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updates to the IFU Intended Use/Indications for Use section to remove the restriction on treatment of calcified lesions, and to revise the warning in relation to emergency surgery availability. |