PMA P110019S074

Device: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS,XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS,XIENCE
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S074
Product code: NIQ
Decision date: 2015-02-06
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: IMPLEMENT AN ALTERNATE DIGESTION SYSTEM USED TO PREPARE PURCHASED STAINLESS STEEL SAMPLES FOR CHEMICAL CHARACTERIZATION.

Current openFDA PMA Record#

Device: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS,XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS,XIENCE
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S074
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2015-02-06
Decision code: OK30
Date received: 2015-01-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: IMPLEMENT AN ALTERNATE DIGESTION SYSTEM USED TO PREPARE PURCHASED STAINLESS STEEL SAMPLES FOR CHEMICAL CHARACTERIZATION.