PMA P110019S062
- Device
- XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S062
- Product code
- NIQ
- Decision date
- 2014-09-04
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR THE POST APPROVAL STUDY LABELING UPDATES FOR THE CLINICAL STUDIES FOLLOWED UNDER THIS PMA FOR THE XIENCE PRIME AND XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENTS.
Current openFDA PMA Record#
- Device
- XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S062
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-09-04
- Decision code
- APPR
- Date received
- 2014-01-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR THE POST APPROVAL STUDY LABELING UPDATES FOR THE CLINICAL STUDIES FOLLOWED UNDER THIS PMA FOR THE XIENCE PRIME AND XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENTS.