|
Device | Lutonix 035 Drug Coated Balloon PTA Catheter |
Generic Name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | LUTONIX 9409 SCIENCE CENTER DR NEW HOPE, MN 55428 |
PMA Number | P130024 |
Supplement Number | S021 |
Date Received | 12/08/2017 |
Decision Date | 02/06/2018 |
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 the revised protocol for the post-approval study (PAS) protocol. |