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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 NameANTENNA AND PORTABLE CHARGER
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable pulse generator system
ApplicantST. JUDE MEDICAL
PMA NumberP010032
Supplement NumberS054
Date Received06/01/2012
Decision Date07/12/2012
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 to reverse the gender of the contacts of the plug and receptacle on the portable charger (models 3711 and 3715) i. E. , a receptacle for connecting the charging antenna will now have female pins for contacts, while the mating plug on the charging antenna will now have male contacts. Additionally, it was requested to change the pin-out connector from a 3 pin version to a 4 pin version.
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