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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.
Classification Namedefibrillator, implantable, dual-chamber
Generic Namedefibrillator, implantable, dual-chamber
4 avenue reaumur
clamart cedex 92140
PMA NumberP980049
Supplement NumberS019
Date Received04/13/2005
Decision Date05/13/2005
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 
Changes to the manufacturing process at international rectifier, leominster, massachusetts and thales, neuilly-sur-seine, france. The modifications include: 1) changing the epoxy resin for encapsulation 2) removing the parylene coating 3) changing the photocoupler and discharge circuits form separate components to a single component coated with epoxy 4) changing the epoxy for attaching the transformer, and 5) adding a silicone cover over certain capacitors prior to the final assembly process.