|
Device | RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMs |
Generic Name | Coronary drug-eluting stent |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P110013 |
Supplement Number | S065 |
Date Received | 04/04/2016 |
Decision Date | 11/30/2017 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the addition of a vendor (Medtronic Ireland) for the Parylene coating process on the Resolute Integrity Stent. |