|
Device | Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) |
Generic Name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | LUTONIX 9409 SCIENCE CENTER DR NEW HOPE, MN 55428 |
PMA Number | P130024 |
Supplement Number | S022 |
Date Received | 01/25/2018 |
Decision Date | 08/29/2018 |
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 an extension of the product matrix to include balloon lengths up to 220 mm for all diameters of the Lutonix 035 Drug Coated Balloon. |