|
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 | S025 |
Date Received | 10/04/2018 |
Decision Date | 12/18/2018 |
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 the addition of 0.018 in guidewire compatibility catheter for the 4 to7 mm diameter balloon sizes, a 3rd radiopaque marker band for balloon lengths greater than 100 mm and a 150 cm length catheter. |