|
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 | S001 |
Date Received | 09/01/2017 |
Decision Date | 10/23/2017 |
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 new balloon length of 100 mm. |