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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
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacemakers
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP900070
Supplement NumberS027
Date Received08/11/2000
Decision Date09/07/2000
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: packager
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the alternate manufacturing facility at innomedica, inc. , minneapolis, mn and the alternate sterilization facility st steris isomedix, minneapolis, mn.
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