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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.
 
DeviceMEDTRONIC VISION SOFTWARE MODEL 9952-SERIES 2.1 AND MEDTRONIC. VISION SOFTWARE MODEL 9952A-SERIES 2.1
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP970012
Supplement NumberS006
Date Received09/22/1998
Decision Date10/15/1998
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for software changes to the Medtronic.Vision Model 9952 Series 2.1 and 9952A Series 2.1 Software.
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