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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.
 
DevicePrecision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, and WaveWriter Alpha Sp
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS359
Date Received12/28/2022
Decision Date01/04/2023
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Use existing equipment at the BSC Dorado facility to perform the laser ablation on the multi-lumen tubes used in the assembly of the D4 and W4 2x4 Splitters, 2x8 Splitters, and M1 Connectors used in the SCS Systems.
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