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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 PROGRAMMABLE DRUG 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 NumberS060
Date Received03/24/2004
Decision Date03/29/2004
Product Code
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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