PMA P110019S136
- Device
- XIENCE Alpine™ Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra™ Everolimus Eluting Coronary Sten
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S136
- Product code
- NIQ
- Decision date
- 2025-08-16
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- to remove a redundant in-process content testing step
Current openFDA PMA Record#
- Device
- XIENCE Alpine™ Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra™ Everolimus Eluting Coronary Sten
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S136
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2025-08-16
- Decision code
- OK30
- Date received
- 2025-07-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to remove a redundant in-process content testing step