- Device
- XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S116
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-03-24
- Decision code
- OK30
- Date received
- 2021-02-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the sub-assembly stent inspection process to increase manufacturing efficiency.