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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceELA RATE-RESPONSIVE PACEMAKERS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
Applicant
LivaNova USA, Inc.
100 cyberonics blvd.
houston, TX 77058
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 change design/components/specifications/material
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; AND2) CHANGING THE MINIMUM SENSING THRESHOLD DURING T-WAVE PROTECTION FROM 2.2 TO 2.5MV.
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