|
Device | STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON |
Generic Name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | The Spectranetics Corp. 6531 Dumbarton Circle Fremont, CA 94555 |
PMA Number | P160049 |
Supplement Number | S003 |
Date Received | 10/01/2018 |
Decision Date | 11/16/2018 |
Product Code |
ONU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a labeling update with 2 year data. |