|
Device | WOLVERINE CORONARY CUTTING BALLOON (MONORAIL AND OVER-THE-WIRE) |
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 | S079 |
Date Received | 11/30/2016 |
Decision Date | 02/09/2017 |
Product Code |
NWX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at Boston Scientific Corporation, Two Scimed Place, Maple Grove, Minnesota, for the ZGlide manufacturing process and application. |