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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 NameELA RATE-RESPONSIVE PACEMAKERS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable rate-responsive cardiac pacemaker & programmer
Regulation Number870.3610
ApplicantELA MEDICAL, INC.
PMA NumberP950029
Supplement NumberS011
Date Received08/18/2000
Decision Date10/11/2000
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval is for the following modifications to your brio family of pacemakers: 1) modify the value for the number of cycles the device will allow before a self test is initiated when the sensor "calls for an elevated pacing rate for a duration or frequency that excees reasonable physiologic limits" from 30,000 to 100,000 cycles; and 2) changing the minimum sensing threshold during t-wave protection from 2. 2 to 2. 5mv.
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