- Device
- Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail)
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S196
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-07-02
- Decision code
- OK30
- Date received
- 2021-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of an automated loading process of corewire and hypotube components and an automated vision system.