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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.
 
DeviceENPULSE IMPLANTABLE PULSE GENERATOR, MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS036
Date Received03/02/2004
Decision Date03/31/2004
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 ADDITION OF THE ATRIAL CAPTURE MANAGEMENT (ACM) AND POST MODE SWITCH OVERDRIVE PACING (PMOP) FEATURES TO ENPULSE IMPLANTABLE PULSE GENERATOR MODELS E1DR01, E1DR03, E1DR06, AND E1DR21. IN ADDITION, YOU REQUESTED APPROVAL FOR MINOR UPDATES TO THE ASSOCIATED PROGRAMMER SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENPULSE IMPLANTABLE PULSE GENERATOR MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE.
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