- Device
- PROMUS Element Plus Everolimus-Eluting Coronary Stent System, Promus PREMIER Everolimus-Eluting Coronary Stent System, P
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S187
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-02-05
- Decision code
- OK30
- Date received
- 2021-01-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of the PROMUS family into the reduced Ethylene Oxide gas concentration sterilization cycle.