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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 Spinal Cord Stimulator (SCS) Systems
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS364
Date Received06/02/2023
Decision Date06/30/2023
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  
New manufacturing site for current supplier Meier Tool & Engineering, Inc. (Meier). Meier manufactures the tacked back-up band, Bluetooth antenna, positive and negative battery contacts, and Printed Circuit Board (PCB) metal spacer components for Boston Scientific Neuromodulation Corporation (BSN) Implantable Pulse Generators (IPGs) and External Trial Stimulators (ETS). These parts are non-patient-contacting components used within the Spinal Cord Stimulator (SCS) and Deep Brain Stimulation (DBS). Meiers proposed facility move to Brooklyn Park, MN was approved for the Paddle Lead Disc Electrodes and Slotted Paddle Disc Electrodes used in SCS Leads.
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