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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.
 
DeviceANTENNA AND PORTABLE CHARGER
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS054
Date Received06/01/2012
Decision Date07/12/2012
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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