PMA P110019S069
- Device
- XIENCE XPEDITION/ XIENCE XPEDITION SV/ XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S069
- Product code
- NIQ
- Decision date
- 2014-09-26
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR A CHANGE TO THE STENT PROCESS MONITORING AND SAMPLING PLAN.
Current openFDA PMA Record#
- Device
- XIENCE XPEDITION/ XIENCE XPEDITION SV/ XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S069
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-09-26
- Decision code
- APPR
- Date received
- 2014-04-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO THE STENT PROCESS MONITORING AND SAMPLING PLAN.