PMA P110019S045
- Device
- XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE XP
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S045
- Product code
- NIQ
- Decision date
- 2013-07-26
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE XP
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S045
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-07-26
- Decision code
- APPR
- Date received
- 2013-05-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.