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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 SYNCHROMED APPLICATION SOFTWARE FOR MODEL 8870, MEDTRONIC INFUSION PUMP SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS055
Date Received11/29/2002
Decision Date12/17/2002
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following two changes to the 8870 synchromed application software, approved as p860004/s052, for use with the n'vision programming system contained on model 8870 application card. The specific changes are: 1) a change to the 8870 synchromed application protocol driver to ensure synchronization and 2) a microprocessor-reset feature to the therapy stop function to reset the stack pointer.
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