|
Device | XIENCE PRIME SV/LL Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIEN |
Generic Name | Coronary drug-eluting stent |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P110019 |
Supplement Number | S105 |
Date Received | 06/12/2019 |
Decision Date | 07/12/2019 |
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 gowning regime and reclassification of the manufacturing environment. |