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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.
 
DeviceProclaim SCS IPG
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS183
Date Received10/22/2021
Decision Date11/16/2021
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 1) Adding an existing Abbott qualified supplier for diode components for 3 types of diodes. 2) Replacing tantalum decoupling capacitors with ceramic capacitors sourced from an existing Abbott qualified supplier; and 3) Reducing the number of tantalum output capacitors on the EPPIC charge pump.
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