|
Device | LUTONIX 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 | S015 |
Date Received | 08/15/2016 |
Decision Date | 10/14/2016 |
Product Code |
ONU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval of changes to the post-approval study for the device. |