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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.
 
DeviceVITATRON C60 DR (MODEL C60A3) AND VITATRON C20 SR (MODEL C20A3) IMPLANTABLE PULSE GENERATORS AND THEIR ASSOCIATED SOFTWA
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP990001
Supplement NumberS017
Date Received02/18/2005
Decision Date03/16/2005
Product Code DXY 
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 THE VITATRON C60 DR (MODEL C60A3) AND VITATRON C20 SR (MODEL C20A3) IMPLANTABLE PULSE GENERATORS AND THEIR ASSOCIATED SOFTWARE (VSF11/VSF12 VERSION 1.0); AND THE T-SERIES APPLICATION SOFTWARE (VSF07/VSF08 VERSION 1.2); AND CD-ROM (VSE03/VSE04 VERSION 2.3).
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