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Food and Drug Administration / Implants / Neuroprosthetics / Cardiac dysrhythmia / Artificial cardiac pacemaker / Implanted cardiac resynchronization device / Implantable cardioverter-defibrillator / Heart failure / Premarket approval / Medicine / Cardiac electrophysiology / Health


P010015.S205, P010031.S381.Approval[removed]pdf
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Document Date: 2014-05-07 17:32:54


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File Size: 113,52 KB

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City

View / New York / Rockville / NE Mounds / /

Company

Regulatory Affairs Specialist Medtronic Inc. / /

Currency

pence / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

MedicalCondition

AV block / /

MedicalTreatment

cardiac resynchronization therapy / /

Organization

Food and Drug Administration / DEPARTMENT OF HEALTH / Center for Devices and Radiological Health / New Hampshire Avenue Document Control Center / U.S. Food and Drug Administration / Radiological Health / Center for Devices / /

Person

Owen P. Faris / Barbara Chiponis / Barbara Chiponis All / Bram D. Zuckerman / Barbara Chiponis Sr. / Silver Spring / /

/

Position

Director / /

Product

WO66-G609 / PMA supplement / /

ProvinceOrState

Maryland / Minnesota / /

Technology

AV / /

URL

www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances / www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm / www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089274 / www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm / /

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