|
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 | S024 |
Date Received | 06/25/2018 |
Decision Date | 09/10/2018 |
Product Code |
ONU |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a change to the balloon wall thickness for the 6 x 220 mm and 7 x 80 - 220 mm balloon sizes as well as a reduction in the labeled introducer sheath compatibility of these device sizes. |