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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS056
Date Received09/17/2001
Decision Date10/15/2001
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MINOR UPDATES TO THE DEVICE SOFTWARE FOR THE PHOTON DR ICD (MODEL V-230HV) AND THE PHOTON MICRO (U) VR/DR ICDS (MODELS V-194/V-232) AND MINOR UPDATED TO THE PROGRAMMER SOFTWARE SUPPORTING THE MODEL 3500 AND MODEL 3510 PROGRAMMERS AS WELL AS THE SOFTWARE SUPPORTING THE PR-1500 AND PR-3500 MODEL PROGRAMMERS.
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