- Device
- Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus ELITE Everolimus-Eluting Platinum C
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S185
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-12-16
- Decision code
- OK30
- Date received
- 2020-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for the addition of a new ISO class 8 Cleanroom to support expansion of the Stent Delivery Catheter production unit