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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.
 
Trade NameCAMERON HEALTH SUBCUTANEOUSIMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantCAMERON HEALTH
PMA NumberP110042
Supplement NumberS032
Date Received04/14/2014
Decision Date04/28/2014
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Boston scientific corporation (bsc) to be the second supplier for the manufacture process of the high voltage capacitor lids to be used in the device.
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