PMA P110010S178
- Device
- Promus Premier, Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S178
- Product code
- NIQ
- Decision date
- 2020-05-06
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Changes to introduce new equipment to the secondary pack process.
Current openFDA PMA Record#
- Device
- Promus Premier, Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S178
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-05-06
- Decision code
- OK30
- Date received
- 2020-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to introduce new equipment to the secondary pack process.