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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 NameEPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND THE MODEL 3307 V 4.6M SOFTWARE
Classification Nameprogrammer, pacemaker
Generic Nametiered therapy implantable defibrillator
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP830045
Supplement NumberS091
Date Received03/22/2004
Decision Date04/09/2004
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of tantalum capacitors in epic+ vr model v-196t and epic+ dr model v-239t pulse generators (p910023/s072) and the model 3307 programmer software v 4. 6m (p830045/s091 and p880086/s099). The device, as modified, will be marketed under the trade name epic+ vr model v-196t and epic+ dr model v-239t and model 3307 programmer software v 4. 6m.
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