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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 NameMEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE DRUG INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP860004
Supplement NumberS077
Date Received09/30/2005
Decision Date11/22/2005
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following modifications: 1) change the composition of the motor coil pin connector material from a phosphor bronze containing some lead to a lead-free phosphor bronze; and 2) modify the weld coating process from one large mound of silicone varnish over both motor coil connector pins to individual mounds over each pin.
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