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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ ADDVENT TEMPO
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacemakers
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP900070
Supplement NumberS026
Date Received01/31/2000
Decision Date02/18/2000
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested the elimination of in-process x-ray imaging for all bradycardia pulse generators.
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