PMA P110010S090
- Device
- PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S090
- Product code
- NIQ
- Decision date
- 2014-09-17
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR CHANGES TO THE ACCESSORY KIT (REMOVAL OF CLIPIT HYPOTUBE CLIPS, SUBSTITUTION OF FLUSHING NEEDLE MANUFACTURED BY NEW VENDOR, MODIFICATION OF CARRIER TUBE CLIP AND UPDATE TO THE EDFU) AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH.
Current openFDA PMA Record#
- Device
- PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S090
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-09-17
- Decision code
- APPR
- Date received
- 2014-06-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE ACCESSORY KIT (REMOVAL OF CLIPIT HYPOTUBE CLIPS, SUBSTITUTION OF FLUSHING NEEDLE MANUFACTURED BY NEW VENDOR, MODIFICATION OF CARRIER TUBE CLIP AND UPDATE TO THE EDFU) AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO