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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
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable rate-responsive cardiac pacemaker & programmer
Regulation Number870.3610
ApplicantELA MEDICAL, INC.
PMA NumberP950029
Supplement NumberS007
Date Received08/26/1999
Decision Date09/16/1999
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the introduction of version 5 of the brio pacemakers, including the introudction ofthe dedicated bipolar model 222.
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