PMA P110019S031
- Device
- XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S031
- Product code
- NIQ
- Decision date
- 2012-11-20
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL TO CHANGE THE MANUFACTURING AND TESTING OF THE ACTIVE PHARMACEUTICAL INGREDIENT (API) USED IN THE MANUFACTURE OF THE DEVICE.
Current openFDA PMA Record#
- Device
- XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S031
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-11-20
- Decision code
- APPR
- Date received
- 2012-08-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO CHANGE THE MANUFACTURING AND TESTING OF THE ACTIVE PHARMACEUTICAL INGREDIENT (API) USED IN THE MANUFACTURE OF THE DEVICE.