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Medical equipment / Cardiac event monitor / Syncope / Medical device / Cardiac electrophysiology / Medtronic / Federal Food / Drug / and Cosmetic Act / Cardiac dysrhythmia / Medicine / Health / Cardiology


Document Date: 2011-06-27 00:48:30

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City

NE Mounds View / /

Company

Reveal DX Systems / EMC / Medtronic Inc. / K103764 Trade / /

Event

FDA Phase / /

/

IndustryTerm

telemetry devices / implantable patient-activated and automatically-activated monitoring systems / announcements concerning your device / predicate devices / reference predicate devices / leadless devices / manufacturing practice requirements / Internet address http /

MedicalCondition

Arrhythmia / chest pain / cardiac arrhythmias / syncope / cardiac arrhythmia / Kxxxxxx (fast) ventricular tachyarrhythmia / suspected arrhythmia / asystole / bradyarrhythmia / dizziness / /

NaturalFeature

Marker Channel / /

Organization

Division of Postmarket Surveillance / Device Evaluation Center for Devices and Radiological Health Enclosure Indication for Use / Center for Devices and Radiological Health / office of Compliance / office of Surveillance / FDA / Cardiovascular Devices Office / HUMAN SERVICES Public Health Service Food and Dru~g Administration / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / /

Person

Yukiko Carson / Silver Spring / Assistane / Yukiko Corson / D. Zuckerman / Insertable Cardiac Monitor / /

/

Position

Model / Assistant / Regulatory Affairs Specialist / /

Product

Model 9529 Insertable Cardiac Monitor (1CM) / Federal Food / K071641 / /

ProvinceOrState

Minnesota / Maryland / /

Technology

design verification / radiation / http / /

URL

http /

SocialTag