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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 NameSYNCHROMED AND SYNCHROMED II IMPLANTABLE INFUSION PUMPS
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC NEUROLOGICAL
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 - software
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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