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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.
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
PMA NumberP890003
Supplement NumberS043
Date Received02/09/1996
Decision Date07/01/1996
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 marketing of a subset of pulse generatros from the approved thera-i/prodigy hardware and software platforms. The devices as modified, will be marketed under the following trade names:medtronic:thera model 7968i pulse generator; prodigy model 8158 pulse generator; preva models 7088, 7089, 8088, and 8089 pulse generators; models 9898e and 9899e software - vitatron:legacy ii models 126/128/526/528/726/728/826/828 pulse generators; visa models 115/116/415/416/425/426/435/436 pulse generators; and model 9849e software.