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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 NameSUBCURANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantCAMERON HEALTH
PMA NumberP110042
Supplement NumberS039
Date Received06/16/2014
Decision Date06/27/2014
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding language in the implant manuals of the referenced devices which states and clarifies that good tissue contact with the electrode and pulse generator is important for optimizing sensing and therapy delivery.
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