|
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 | S014 |
Date Received | 07/05/2016 |
Decision Date | 11/14/2016 |
Product Code |
ONU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a shelf life extension from 24 to 36 months. |