PMA P110019S094
- Device
- XIENCE Sierra Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S094
- Product code
- NIQ
- Decision date
- 2018-05-22
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval for changes to the stent geometry, delivery system, and packaging materials.
Current openFDA PMA Record#
- Device
- XIENCE Sierra Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S094
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2018-05-22
- Decision code
- APPR
- Date received
- 2017-09-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the stent geometry, delivery system, and packaging materials.