|
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 | S005 |
Date Received | 04/08/2019 |
Decision Date | 05/03/2019 |
Product Code |
ONU |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Extension of the drug substance retest period and modification of heavy metals testing requirements. |