|
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 | S008 |
Date Received | 11/09/2015 |
Decision Date | 11/24/2015 |
Product Code |
ONU |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO PROVIDE DETAILS REGARDING THE USE OF BARE METAL STENTS WITH THE DEVICE FOR BAILOUT STENTING. |