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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 DR+ PULSE GENERATOR MODELS 2360L AND 2364L PULSE GENERATORS MODELS 2360L AND 2364L
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantPACESETTER, INC.
PMA NumberP880086
Supplement NumberS037
Date Received08/01/1996
Decision Date06/30/1997
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for themodel 3250 apsu programmer with model 3263 software and model 3251 base station with model 3265 software.
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