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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 SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantCAMERON HEALTH, INC
PMA NumberP110042
Supplement NumberS002
Date Received12/10/2012
Decision Date03/07/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for new sources and formulations of battery cell materials.
Approval Order Approval Order
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