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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.
 
DeviceALL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, ORCHESTRA PLUS PROGRAMMER AND ELAVIEW 2.02 PROGRAMMING SOFTWARE
Classification Namedefibrillator, implantable, dual-chamber
Generic Namedefibrillator, implantable, dual-chamber
Applicant
SORIN GROUP- CRM
4 avenue reaumur
clamart cedex 92140
PMA NumberP980049
Supplement NumberS025
Date Received01/24/2007
Decision Date06/29/2007
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL FOR THE ORCHESTRA PLUS PROGRAMMER AND ELAVIEW 2.02 PROGRAMMING SOFTWARE.
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