PMA P110019S040

Device: XIENCE PRIME/ XIENCE PRIME LL / XIENCE EXPEDITION/ XIENCE EXPEDITION SV AND LL EVEROLIMUS ELUTING CORONARY STENT SYTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S040
Product code: NIQ
Decision date: 2013-02-20
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: SHORTEN THE SHELF-LIFE OF A SOLVENT USED FOR THE MANUFACTURING OF THE DEVICES.

Current openFDA PMA Record#

Device: XIENCE PRIME/ XIENCE PRIME LL / XIENCE EXPEDITION/ XIENCE EXPEDITION SV AND LL EVEROLIMUS ELUTING CORONARY STENT SYTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S040
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2013-02-20
Decision code: OK30
Date received: 2013-01-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: SHORTEN THE SHELF-LIFE OF A SOLVENT USED FOR THE MANUFACTURING OF THE DEVICES.