PMA P110019S140
- Device
- XIENCE Alpine Everolimus Eluting Coronary Stent System; XIENCE Sierra Everolimus Eluting Coronary Stent System; XIENCE P
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S140
- Product code
- NIQ
- Decision date
- 2026-02-13
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- changes to the bottle cleaning process
Current openFDA PMA Record#
- Device
- XIENCE Alpine Everolimus Eluting Coronary Stent System; XIENCE Sierra Everolimus Eluting Coronary Stent System; XIENCE P
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S140
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-02-13
- Decision code
- OK30
- Date received
- 2026-01-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the bottle cleaning process