PMA P110010S193
- Device
- Promus Premier™ and Promus Elite™ Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S193
- Product code
- NIQ
- Decision date
- 2021-05-27
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Update to the incoming verification of the active pharmaceutical ingredient (API) everolimus.
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
- S193
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-05-27
- Decision code
- OK30
- Date received
- 2021-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the incoming verification of the active pharmaceutical ingredient (API) everolimus.