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Premarket approval / Center for Devices and Radiological Health / Medical device / Coronary stent / Federal Food / Drug / and Cosmetic Act / Percutaneous coronary intervention / Paclitaxel / Title 21 of the Code of Federal Regulations / Adverse event / Medicine / Food and Drug Administration / Health


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue
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Document Date: 2013-12-05 19:21:37

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File Size: 329,12 KB

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City

Rockville / /

Company

Wire Systems / Young Senior Regulatory Affairs Specialist Boston Scientific Corporation / /

Currency

pence / /

Event

FDA Phase / /

IndustryTerm

Internet HomePage / similar device / malfunctioned and such device / diagnostic devices / metal stent restenotic lesions / /

MedicalCondition

true posterior myocardial infarction / acute ST-segment elevation myocardial infarction / left bundle branch block / left bundle myocardial infarction / serious injury / acute myocardial infarction / /

MedicalTreatment

angioplasty / /

Organization

Radiological Health PMA Document Mail Center / Food and Drug Administration / Center for Devices and Radiological Health / Radiological Health / Cardiovascular Devices Office / U.S. Food and Drug Administration Center for Devices / DEPARTMENT OF HEALTH / Center for Devices / /

Person

Melissa C. Young / Silver Spring / /

/

Product

Paclitaxel / TAXUS Express Stent Coronary Eluting Coronary Stent System / PMA supplement / /

ProvinceOrState

Minnesota / Maryland / /

PublishedMedium

The TAXUS Express / /

URL

www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm / http /

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