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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.
 
DeviceSYNCHROMED II INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS065
Date Received12/16/2004
Decision Date02/22/2005
Product Code
LKK
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modifications to the 1) protocol driver for the synchromed ii application software, 2) synchromed ii application software, and 3) final functional test (fft) manufacturing software.
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