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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 MODEL 2090 BURBOT AND SPLAKE PROGRAMMERS
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS120
Date Received05/14/2007
Decision Date06/07/2007
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate hard disk drive (hdd) used on medtronic model 2090 ?burbot? that also includes a minor design change and an alternate floppy disc drive (fdd) used on both medtronic model 2090 ?splake? and ?burbot? carelink programmers.
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