PMA P110010S071
- Device
- PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S071
- Product code
- NIQ
- Decision date
- 2014-02-27
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- REDUCTION IN INSPECTION WAIT TIME FOR A MOLDED MANIFOLD COMPONENT.
Current openFDA PMA Record#
- Device
- PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S071
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-02-27
- Decision code
- OK30
- Date received
- 2014-01-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REDUCTION IN INSPECTION WAIT TIME FOR A MOLDED MANIFOLD COMPONENT.