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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received12/23/2011
Decision Date09/28/2012
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 12M-1048
Notice Date 11/01/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00399217
NCT00853645
NCT01064076
NCT01085435
NCT01117792
NCT01161589
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the subcutaneous implantable defibrillator (s-icd) system. This device is indicated to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with antitachycardia pacing.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S031 S032 S033 S034 S035 S037 S039 
S040 
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