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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMODEL 3550-39 TITAN ANCHOR
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS135
Date Received04/07/2009
Decision Date09/02/2009
Product Code LGW 
Advisory Committee Neurology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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