PMA P110019S072

Device: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM; LL,; SV; XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTE
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S072
Product code: NIQ
Decision date: 2014-10-22
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: CHANGE TO THE TIMING OF SAMPLING FOR PARTICULATE TESTING FOR PRODUCT RELEASE TESTING.

Current openFDA PMA Record#

Device: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM; LL,; SV; XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTE
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S072
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2014-10-22
Decision code: OK30
Date received: 2014-09-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE TIMING OF SAMPLING FOR PARTICULATE TESTING FOR PRODUCT RELEASE TESTING.