PMA P110019S080
- Device
- XIENCE PRIME,XIENCE XPEDITION, XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S080
- Product code
- NIQ
- Decision date
- 2016-04-27
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval for extending the shelf-life of a solvent from 4 months to 12 months.
Current openFDA PMA Record#
- Device
- XIENCE PRIME,XIENCE XPEDITION, XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S080
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2016-04-27
- Decision code
- APPR
- Date received
- 2015-11-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for extending the shelf-life of a solvent from 4 months to 12 months.