PMA P110010S145
- Device
- Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S145
- Product code
- NIQ
- Decision date
- 2017-09-13
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Removal of a redundant inspection step.
Current openFDA PMA Record#
- Device
- Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S145
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2017-09-13
- Decision code
- OK30
- Date received
- 2017-08-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of a redundant inspection step.