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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 NameST. JUDE MEDICAL ADAPTER
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable pulse generator system
ApplicantST. JUDE MEDICAL
PMA NumberP010032
Supplement NumberS083
Date Received07/10/2014
Decision Date10/15/2014
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor design changes to the single 8 extension (model 3383) to introduce a new 8-channel adapter (models 2311 and 2316) for spinal cord stimulation (scs) systems. The new 8-channel adapter is intended to connect a compatible 8-channel medtronic lead or extension to a st. Jude medical implantable pulse generator.
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