|
Device | RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY SYSTEM (RX AND OTW) |
Generic Name | Coronary drug-eluting stent |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P110013 |
Supplement Number | S020 |
Date Received | 07/18/2013 |
Decision Date | 09/05/2013 |
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 CHANGING THE SAMPLING SCHEME USED FOR ANALYTICAL LOT RELEASE TESTING FOR THE DEVICES. |