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Food and Drug Administration / Cardiac electrophysiology / Clinical research / Implants / Neuroprosthetics / Premarket approval / Medical device / Implanted cardiac resynchronization device / Federal Food / Drug / and Cosmetic Act / Medicine / Technology / 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 18:51:16

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File Size: 343,52 KB

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City

St. Paul / Rockville / /

Company

Cox / Flaig Regulatory Affairs Boston Scientific Corporation / Boston Scientific / ICD / CRT-D / /

Currency

pence / /

Event

FDA Phase / Product Issues / Product Recall / /

Facility

MADIT-CRT PAS inAmerican College of CardiologyNational CardiovascularData Registry / /

IndustryTerm

Internet HomePage / malfunctioned and such devices / diagnostic devices / similar devices / active device / restricted devices / control / /

MedicalCondition

severe heart failure / ischemic heart failure / subsequent heart failure / Left bundle branch block / serious injury / heart failure / /

Organization

Radiological Health PMA Document Mail Center / Food and Drug Administration / Center for Devices and Radiological Health / Christy Foreman Acting Director Office / Radiological Health / MADIT-CRT PAS inAmerican College of CardiologyNational CardiovascularData Registry / NCDR PAS / U.S. Food and Drug Administration Center for Devices / DEPARTMENT OF HEALTH / Center for Devices / /

Person

Silver Spring / Ken Skodacek / /

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Product

requirements / PMA / PMA supplement / /

ProvinceOrState

Minnesota / Maryland / /

Technology

approved protocol / /

URL

www.fda.Guidace/GuidanceDo / http /

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