- Device
- Xience Prime, Xience Prime SV, Xience Prime LL, Xience Xpedition, Xience Xpedition SV, Xience Xpedition LL, Xience Alpin
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S100
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2018-04-16
- Decision code
- OK30
- Date received
- 2018-03-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate contract laboratory for raw material lot release tests.