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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 II PROGRAMMABLE DRUG INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP860004
Supplement NumberS060
Date Received03/24/2004
Decision Date03/29/2004
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
Recalls CDRH Recalls
Approval Order Statement 
Approval for the following changes involving the motor coil for the synchromed ii implantable infusion pump: 1) change from a crimped to a heat-welded motor coil connector pin; and 2) change to a silicon varnish surface coating of the motor coil, the same coating as applied to the motor coil of the synchromed el implantable infusion pump.
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