IOPN PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
FDA premarket approval P100023/S053 · decided 2012-09-27
Approval details
- PMA number
- P100023
- Supplement
- S053
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IOPN PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corp
- Date received
- 2012-08-24
- Decision date
- 2012-09-27
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR REMOVAL OF THE BALL FROM THE TIP OF THE COREWIRE WHICH ISLOCATED BETWEEN THE INNER AND OUTER LUMEN OF THE STENT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND ION PACLITAXEL-ELUTING PLATINUM CHROMIUMCORONARY STENT SYSTEM AND ARE INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE
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