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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 AND SYNCHROMED II IMPLANTABLE INFUSION PUMPS
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS059
Date Received02/23/2004
Decision Date03/17/2004
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: the addition of time labels and a daily dose filed to the programming screens; the addition of recently approved catheter models, model 8731 and model 8749, to the drop-down list; changes to the screen used to enter the demo mode, and the resulting updates to the programming guides.
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