|
Device | Stellarex 0.035 OTW Drug-coated Angioplasty Ballon |
Generic Name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | The Spectranetics Corp. 6531 Dumbarton Circle Fremont, CA 94555 |
PMA Number | P160049 |
Supplement Number | S007 |
Date Received | 09/03/2019 |
Decision Date | 09/13/2019 |
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 updates to the device labeling. |