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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 MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Classification Namedefibrillator, implantable, dual-chamber
Generic Namedefibrillator, implantable, dual-chamber
Applicant
SORIN GROUP- CRM
4 avenue reaumur
clamart cedex 92140
PMA NumberP980049
Supplement NumberS018
Date Received01/31/2005
Decision Date02/28/2005
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN STERILIZATION PROCESS PARAMETERS.
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