PMA P110010S179
- Device
- Promus Premier, Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S179
- Product code
- NIQ
- Decision date
- 2020-06-09
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Automation of the visual inspection for evaluating the packaging seal width.
Current openFDA PMA Record#
- Device
- Promus Premier, Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S179
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-06-09
- Decision code
- OK30
- Date received
- 2020-06-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automation of the visual inspection for evaluating the packaging seal width.