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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 NameBRIO CARDIAC PACEMAKERS DUAL CHAMBER/DUAL CHAMBER RATE RESPONSIVE
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator, pacemaker
Regulation Number870.3610
ApplicantELA MEDICAL, INC.
PMA NumberP950029
Supplement NumberS005
Date Received02/26/1999
Decision Date08/25/1999
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 access to programmable rest-rate and non-invasive physiological stimulation (nips) parameters. The device is indicated for dual-chamber cardiac pacing with the ability to perform limited non-invasive electrophysiological studies.
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