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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) APPLICATION SOFTWARE MODEL 9809
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS095
Date Received10/20/2005
Decision Date11/22/2005
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a software update, software series 5. 0 to software series 6. 0, to correct a minor customer inconvenience anomaly with telemetry error conditions related to the retry strategy by addition of an enhancement check to ensure that all of the event data has been received.
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