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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
Applicant
Abbott Medical
6901 preston road
plano, TX 75024
PMA NumberP010032
Supplement NumberS159
Date Received02/03/2020
Decision Date03/04/2020
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of an alternative sampling plan for bacterial endotoxin testing performed at the Arecibo, Puerto Rico facility.
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