- Device
- Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S194
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-04-29
- Decision code
- APPR
- Date received
- 2021-06-04
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for removing a wash step during stent cleaning and preparation.