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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 NameMODEL 3550-39 TITAN ANCHOR
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS135
Date Received04/08/2009
Decision Date09/02/2009
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
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: 1) removal of the xylene mixing step; 2) addition of a secondary silicone adhesive step and cure; and 3) modification of the incoming receiving inspection process with the addition of a process monitor.
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