|
Device | LUTONIX DRUG COATED BALLOON (DCB) |
Generic Name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | LUTONIX 9409 SCIENCE CENTER DR NEW HOPE, MN 55428 |
PMA Number | P130024 |
Supplement Number | S001 |
Date Received | 11/24/2014 |
Decision Date | 01/22/2015 |
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 IN BALLOON PROTECTOR FROM A SLIDE-OFF TO A PEELAWAY DESIGN. |