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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.
 
DeviceAlternative Active Anchor (part number 104504)
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantSaluda Medical Pty, Ltd.
Level 1, 407 Pacific Hwy.
Atarmon NSW 2064
PMA NumberP190002
Supplement NumberS027
Date Received02/16/2024
Decision Date05/16/2024
Product Codes LGW QRB 
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 for the alternative active anchor (part number 104504) which includes the following modifications 1) the curvature of the clamping surface of the bottom clamp plate changed from 0.9mm to 0.66m, and a 0.4mm chamfer was added to the lead edge to facilitate lead insertion, 2) the curved clamping surface of the top clamp plate was removed so that the clamping surface is flat, and 3) the silicone sleeve was removed from within the clamping surfaces.
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