PMA P110019S141
- Device
- XIENCE Alpine™, XIENCE Sierra™, XIENCE PRO™ S, and XIENCE Skypoint™ Everolimus Eluting Coronary Stent Systems
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S141
- Product code
- NIQ
- Decision date
- 2026-05-22
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- reduced confirmatory testing of Everolimus BHT reference standard
Current openFDA PMA Record#
- Device
- XIENCE Alpine™, XIENCE Sierra™, XIENCE PRO™ S, and XIENCE Skypoint™ Everolimus Eluting Coronary Stent Systems
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S141
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-05-22
- Decision code
- OK30
- Date received
- 2026-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reduced confirmatory testing of Everolimus BHT reference standard