|
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 | S036 |
Date Received | 02/18/2014 |
Decision Date | 03/19/2014 |
Product Code |
NIQ |
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 CHANGES TO HOW EXTRUDED COMPONENTS ARE PHYSICALLY GROUPED AND TO THE WAY SAMPLES ARE SELECTED FOR IN-PROCESS TESTING. |