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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 NameMEDTRONIC(R) THERA(TM) PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS037
Date Received04/06/1995
Decision Date10/31/1995
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modified reduced size versions of the thera dr (approved under p890003/s31). The devices, as modified, will be marketed under the trade name:medtronic thera-i series and prodigy pulse generators, model 9879 software, and models 9759/9772 memorymods.
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