PMA P110010S197
- Device
- PROMUS Premier and PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S197
- Product code
- NIQ
- Decision date
- 2021-08-16
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Change to the analytical chemistry method for evaluating drug content.
Current openFDA PMA Record#
- Device
- PROMUS Premier and PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S197
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-08-16
- Decision code
- OK30
- Date received
- 2021-07-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the analytical chemistry method for evaluating drug content.