PMA P110019S025
- Device
- XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S025
- Product code
- NIQ
- Decision date
- 2012-12-21
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR A NEWLY DESIGNED DELIVERY CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME XIENCE XPEDITION; XIENCE XPEDITION SMALL VESSEL (SV) AND XIENCE XPEDITION LONG LESION (LL) EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN SUBJECTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 32MM) WITH REFERENCE VESSEL DIAMETER OF >=2.25MM TO >=4.25MM.
Current openFDA PMA Record#
- Device
- XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S025
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-12-21
- Decision code
- APPR
- Date received
- 2012-06-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEWLY DESIGNED DELIVERY CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME XIENCE XPEDITION; XIENCE XPEDITION SMALL VESSEL (SV) AND XIENCE XPEDITION LONG LESION (LL) EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN SUBJECTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH =2.25MM TO >=4.25MM.