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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(R) THERA(R) VDD, MODEL 896I, PRODIGY(TM) VDD, MODEL 8168 PULSE GENERATORS AND CAPURE(R) VDD, MODEL 5032 LEAD,
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS039
Date Received04/20/1995
Decision Date03/22/1996
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC THERA VDD MODEL 8968I AND PRODIGY VDD MODEL 8168 PULSE GENERATORS, MODEL 5032 CAPSURE VDD LEAD, MODEL 9879E SOFTWARE, AND MODEL 9759 MEMORYMOD
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