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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 NameUNITY MODEL 292-06 SINGLE PASS PULSE GENERATOR
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator and programmer
Regulation Number870.3610
ApplicantINTERMEDICS, INC.
PMA NumberP910020
Supplement NumberS012
Date Received09/11/1995
Decision Date07/31/1996
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 the unity model 292-07 single pass (vddr) pulse generator with unipass leads models 425-02, 425-04 and 425-06 and model 531-60 graphics program module. The device, as modified, will be marketed under the trade name unity.
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