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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 PUMP
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP860004
Supplement NumberS074
Date Received08/12/2005
Decision Date11/03/2005
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of nusil 1137 silicone adhesive to the catheter fitting o-ring assembly.
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