PMA P110019S087

Device: XIENCE PRIME,XIENCE Xpedition,XIENCE Alpine,Everolimus Eluting Coronary Stent System, SV (2.25) LL
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S087
Product code: NIQ
Decision date: 2017-02-21
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
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.

Current openFDA PMA Record#

Device: XIENCE PRIME,XIENCE Xpedition,XIENCE Alpine,Everolimus Eluting Coronary Stent System, SV (2.25) LL
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S087
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2017-02-21
Decision code: APPR
Date received: 2016-09-12
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.