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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.
 
DeviceEPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP910023
Supplement NumberS072
Date Received03/22/2004
Decision Date04/09/2004
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
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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