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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.
 
DeviceMEDTRONIC INSYNC 11 PROTECT MODEL 7295 WITH THE MODEL 9992 APPLICATION SOFTWARE
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP010031
Supplement NumberS008
Date Received08/21/2003
Decision Date02/06/2004
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC INSYNC II PROTECT MODEL 7295 WITH MODEL 9992 APPLICATION SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC INSYNC II PROTECT MODEL 7295 WITH MODEL 9992 APPLICATION SOFTWARE AND IS INDICATED AS FOLLOWS: THE INSYNC II PROTECT PROVIDES VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A QRS DURATION >= 130 MS. THE INSYNC II PROTECT DEVICE ONLY ALLOWS ARRHYTHMIAS IN THE VF ZONE TO RECEIVE TREATMENT. ARRHYTHMIAS IN THE MONITOR ONLY ZONE WILL NOT BE TREATED BY THE DEVICE.
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