PMA P110019S053
- Device
- XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM ; XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S053
- Product code
- NIQ
- Decision date
- 2014-02-28
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE LABELING TO REFLECT THE THREE YEAR POST APPROVAL STUDY FINDINGS FROM THE SPIRIT PRIME CLINICAL TRIAL.
Current openFDA PMA Record#
- Device
- XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM ; XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S053
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-02-28
- Decision code
- APPR
- Date received
- 2013-08-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE LABELING TO REFLECT THE THREE YEAR POST APPROVAL STUDY FINDINGS FROM THE SPIRIT PRIME CLINICAL TRIAL.