|
Device | LUTONIX 035 DRUG COATED BALLOON PTA CATETER |
Generic Name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | LUTONIX 9409 SCIENCE CENTER DR NEW HOPE, MN 55428 |
PMA Number | P130024 |
Supplement Number | S013 |
Date Received | 06/15/2016 |
Decision Date | 11/09/2016 |
Product Code |
ONU |
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 | Yes |
Approval Order Statement Approval for a manufacturing site located at Lutonix Inc., 9409 Science Center Drive, New Hope, Minnesota to manufacture 7mm balloons. |