- Device
- PROMUS Element™ Plus Everolimus-Eiuting Stent System I, PROMUS PREMIER Everolimus-Eiuting Platinum Chromium Coronary
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S142
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2017-07-24
- Decision code
- OK30
- Date received
- 2017-06-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Optimized BSC2000-2 EO sterilization cycle in Chambers 8 and 9 at Synergy Health Tullamore.