PROMUS ELEMENT PLUS EVEROLIMUS-ELEUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA premarket approval P110010/S035 · decided 2013-03-25
Approval details
- PMA number
- P110010
- Supplement
- S035
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROMUS ELEMENT PLUS EVEROLIMUS-ELEUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corp
- Date received
- 2012-11-05
- Decision date
- 2013-03-25
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR MODIFYING THE PRECAUTIONS REGARDING LONGITUDINAL STENT DEFORMATION IN THE DIRECTIONS FOR USE.
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