PMA P110010S084
- Device
- PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S084
- Product code
- NIQ
- Decision date
- 2014-05-22
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- CHANGE TO USE A COLOR CAMERA FOR THE DISTAL TIP INSPECTION PROCESS.
Current openFDA PMA Record#
- Device
- PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S084
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-05-22
- Decision code
- OK30
- Date received
- 2014-04-23
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO USE A COLOR CAMERA FOR THE DISTAL TIP INSPECTION PROCESS.