- Device
- Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S190
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-03-24
- Decision code
- OK30
- Date received
- 2021-02-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the acceptance criteria for the population of white phase precipitate present in platinum chromium alloys (PCA) tubing.