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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.
 
DeviceTRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO
Generic NameProgrammer, pacemaker
Regulation Number870.3700
ApplicantSt. Jude Medical, Inc.
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP830045
Supplement NumberS068
Date Received01/31/2000
Decision Date02/18/2000
Withdrawal Date06/20/2007
Product Code KRG 
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  
The 30-day notice requested the elimination of in-process x-ray imgaing for all bradycardia pulse generators.
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