PMA P110019S009
- Device
- XIENCE PRIME AND XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S009
- Product code
- NIQ
- Decision date
- 2012-09-14
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL TO UPDATE THE PRODUCT LABELING CONTAINED IN THE INSTRUCTIONS FOR USE (IFU) AND PATIENT GUIDE FOR THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND FOR THE XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THESE UPDATES SPECIFICALLY INCLUDED LONGER TERM FOLLOW-UP DATA TO ALLAPPLICABLE CLINICAL TRIALS FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- XIENCE PRIME AND XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S009
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-09-14
- Decision code
- APPR
- Date received
- 2012-01-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL TO UPDATE THE PRODUCT LABELING CONTAINED IN THE INSTRUCTIONS FOR USE (IFU) AND PATIENT GUIDE FOR THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND FOR THE XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THESE UPDATES SPECIFICALLY INCLUDED LONGER TERM FOLLOW-UP DATA TO ALLAPPLICABLE CLINICAL TRIALS FOR THE DEVICES.