- Device
- Promus Element Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Premier Everolimus-Eluting Platinum Ch
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S174
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-02-06
- Decision code
- OK30
- Date received
- 2020-01-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of incoming raw material testing and specifications for PVDF-HFP.