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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 INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS138
Date Received08/10/2010
Decision Date03/03/2011
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 Yes
Approval Order Statement 
Approval of the following manufacturing process changes related to the baseline test of the implantable synchromed ii infusion pump, model 8637: 1) automation of the transfer of baseline test data; 2) change the duty cycle and lower the specification limit of the dynamic current test; and 3) an increase to the time to measure the micro awake current.
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