|
Device | Resolute Integrity RX Coronary Stent System & Resolute Integrity OTW Cornary Stent System |
Generic Name | Coronary drug-eluting stent |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P110013 |
Supplement Number | S082 |
Date Received | 09/14/2017 |
Decision Date | 10/13/2017 |
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 the work steps used in the manufacture of the bare metal stent. |