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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.
 
DeviceBRIO, TALENT, AND OPUS PACEMAKERS AND PROGRAMMER SOFTWARE
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 NumberS013
Date Received01/11/2001
Decision Date02/02/2001
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 FOR A NEW DIGITAL PACING CHIP, THE LOGAUTO H5, BRIO AND TALENT FIRMWARE MASK L4, AND CSO VERSION 4.16UG PROGRAMMER SOFTWARE.
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