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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCADENCE ICDS
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP910023
Supplement NumberS145
Date Received07/19/2007
Decision Date08/17/2007
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ALTERNATE SUPPLIER FOR THE DIODE DIE, SILICON, 20V, 5%, ZENAR VOLTAGE REGULATORY, AND THE DIODE DIE, HIGH VOLTAGE, HIGH CURRENT COMPONENTS FOR THE DEVICE.
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