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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 REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) WITH UPDATED TO THE APPLICATION SOFTWARE (MODEL 09-9 SERIES 2.0)
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS062
Date Received04/11/2001
Decision Date05/07/2001
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 THE MEDTRONIC MODEL 9809 SERIES 2.0 SOFTWARE FOR USE WITH THE MEDTRONIC MODEL 9790 PROGRAMMER SERIES FOR USE IN PROGRAMMING THE MODEL 9526 REVEAL IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR.
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