- Device
- Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S191
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-04-22
- Decision code
- OK30
- Date received
- 2021-03-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative process to allow for the automation of top assembly process steps for the manufacture of stent delivery catheters.