PMA P110019S110
- Device
- Xience Sierra Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S110
- Product code
- NIQ
- Decision date
- 2020-02-13
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Modification to the Stent Press process for the XIENCE 4.0 mm diameter stent.
Current openFDA PMA Record#
- Device
- Xience Sierra Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S110
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-02-13
- Decision code
- OK30
- Date received
- 2020-01-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the Stent Press process for the XIENCE 4.0 mm diameter stent.