PMA P110019S063
- Device
- XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S063
- Product code
- NIQ
- Decision date
- 2014-07-03
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL TO REMOVE A STENT INSPECTION STEP.
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
- S063
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-07-03
- Decision code
- APPR
- Date received
- 2014-01-31
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO REMOVE A STENT INSPECTION STEP.