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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) System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS192
Date Received09/15/2022
Decision Date04/28/2023
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 a change in cleanroom classification from ISO 8 to ISO 9 in the Controlled Access Environment (CAE) room in Abbott's Arecibo, Puerto Rico (PR) manufacturing site and a diameter nozzle change for the mold release spray. The change is being made to align with the cleanroom classification for the same manufacturing operations and processes in Plano, TX. Abbott is also seeking this higher classification to accommodate for the change in the larger diameter mold release spray.
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