PMA P110019S088
- Device
- XIENCE PRIME /XIENCE XPEDITION /ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S088
- Product code
- NIQ
- Decision date
- 2016-12-19
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Alternative sample preparation method for the analysis of the residual solvent and BHT content.
Current openFDA PMA Record#
- Device
- XIENCE PRIME /XIENCE XPEDITION /ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S088
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2016-12-19
- Decision code
- OK30
- Date received
- 2016-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative sample preparation method for the analysis of the residual solvent and BHT content.