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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 NameSUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantCAMERON HEALTH, INC
PMA NumberP110042
Supplement NumberS004
Date Received01/11/2013
Decision Date02/21/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the patient screening instructions in the sq-rx pulse generator user manual.
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