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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.
 
DevicePARAGON, PHOENIX, MULTILOG & SENSORITHM PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantSt. Jude Medical, Inc.
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP830045
Supplement NumberS101
Date Received07/13/2006
Decision Date08/09/2006
Withdrawal Date06/20/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO AN AUTOMATED SELECTIVE SOLDERING PROCESS AS AN ALTERNATE METHOD FOR THE SOLDERING ON THE PEPIN BOARD OF THE MODEL 3650 MERLIN PCS.
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