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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 NameTALENT AND BRIO PACEMAKERS (RIGID CONNECTOR)
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable rate-responsive cardiac pacemaker & programmer
Regulation Number870.3610
ApplicantELA MEDICAL, INC.
PMA NumberP950029
Supplement NumberS010
Date Received09/27/2000
Decision Date10/10/2000
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 to change the header material in the talent and brio pacemakers from silicone rubber to tecothane 75d polyurethane.
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