PMA P110010S198
- Device
- Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System; Promus ELITE Everolimus-Eluting Platinum Chro
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S198
- Product code
- NIQ
- Decision date
- 2021-09-22
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Change to a design verification production process control.
Current openFDA PMA Record#
- Device
- Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System; Promus ELITE Everolimus-Eluting Platinum Chro
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S198
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-09-22
- Decision code
- OK30
- Date received
- 2021-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to a design verification production process control.