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. |
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Device | EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND THE MODEL 3307 V 4.6M SOFTWARE |
Generic Name | Programmer, pacemaker |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P830045 |
Supplement Number | S091 |
Date Received | 03/22/2004 |
Decision Date | 04/09/2004 |
Withdrawal Date
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06/20/2007 |
Product Codes |
DXY KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-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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