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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.
 
DeviceTALENT MODEL 213 DUAL-CHAMBER, DUAL SENSOR, IMPLANTABLE CARDIAC PACEMAKER, ELA MEDICAL PROGRAMMER
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
Applicant
SORIN GROUP- CRM
4 avenue reaumur
clamart cedex 92140
PMA NumberP950029
Supplement NumberS006
Date Received08/23/1999
Decision Date05/18/2000
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the introduction of Talent Rate Responsive Pacemaker Models DR213, DR223, and SR113; the Optus G Rate Responsive Pacemaker Models 4621 and 4624; and the CSO 4.12 Programming Software.
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