PMA P110019S048
- Device
- XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S048
- Product code
- NIQ
- Decision date
- 2014-06-02
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL TO MODIFY THE IN VITRO DRUG RELEASE SPECIFICATIONS FOR THE DEVICES.
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
- S048
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-06-02
- Decision code
- APPR
- Date received
- 2013-06-28
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO MODIFY THE IN VITRO DRUG RELEASE SPECIFICATIONS FOR THE DEVICES.