PMA P110019S138
- Device
- XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine), XIENCE Sierra Everolimus Eluting Coronary Stent
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S138
- Product code
- NIQ
- Decision date
- 2026-02-03
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- changes to hypotube tip cleaning protocols
Current openFDA PMA Record#
- Device
- XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine), XIENCE Sierra Everolimus Eluting Coronary Stent
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S138
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-02-03
- Decision code
- OK30
- Date received
- 2026-01-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to hypotube tip cleaning protocols