|
Device | RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM |
Generic Name | Coronary drug-eluting stent |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P110013 |
Supplement Number | S011 |
Date Received | 04/10/2013 |
Decision Date | 08/22/2013 |
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 A CHANGE TO THE SAMPLE PREPARATION EXTRACTION SOLUTION AND DILUENTS FOR THE BUTYLATED HYDROXYTOLUENE (BHT) ANALYTICAL QUALITY CONTROL TEST. |