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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.
 
DeviceREGENCY,SENSOLOG AND DIALOG PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantSt. Jude Medical, Inc.
15900 VALLEY VIEW Court
SYLMAR, CA 91342
PMA NumberP880006
Supplement NumberS039
Date Received02/17/2006
Decision Date07/28/2006
Withdrawal Date 05/07/2018
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.
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