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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.
 
DeviceSpinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS249
Date Received03/27/2026
Decision Date04/25/2026
Product Codes LGW QRB 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
incorporate an additional inspection step to provide enhanced assurance of device reliability and safety; this change adds a manufacturing functional test to verify Bluetooth Low Energy (BLE) communication functionality of devices prior to distribution
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