|
Device | XIENCE PRIME,XIENCE Xpedition,XIENCE Alpine,Everolimus Eluting Coronary Stent System, SV (2.25) LL |
Generic Name | Coronary drug-eluting stent |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P110019 |
Supplement Number | S087 |
Date Received | 09/12/2016 |
Decision Date | 02/21/2017 |
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 Fourier Transform Near Infra-Red Spectroscopy (FT-NIR), which will be used as an alternate test method to high performance liquid chromatography (HPLC) methods for drug coating solution analysis. |