|
Device | XIENCE PRIME/SV/LL and XIENCE/SV/LL and XIENCE Alpine and XIENCE Sierra Everolimus Eluting Coronary Stent System |
Generic Name | Coronary drug-eluting stent |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P110019 |
Supplement Number | S097 |
Date Received | 01/26/2018 |
Decision Date | 02/21/2018 |
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 Change the time point when pyrogen testing for ethylene oxide (EO) sterilized products is conducted for products manufactured at its facility located in Clonmel, Ireland. |