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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.
 
DeviceMaster Activa®, Percept and SenSight Deep Brain Stimulation Therapy System
Generic NameStimulator, thalamic, epilepsy, implanted
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS438
Date Received08/29/2022
Decision Date01/08/2024
Product Codes MBX MHY NHL PJS 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the following: For P960009/S438, approval for: • Model B35300 Percept RC Implantable Neurostimulator (INS)• Model RS6230 Recharger Kit (including the WR9230 Recharger)• Model A610 Clinician Programmer Application (PPA) Software (Version 4.0) • Model A620 Patient Programmer Application (CPA) (Version 3.0) • A90300 Recharger Application Software (RAS) (Version 2.0) • Labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new Percept RC System.For H020007/S329, approval for: • Model B35300 Percept RC Implantable Neurostimulator (INS)• Model RS6230 Recharger Kit (including the WR9230 Recharger)• Model A610 Clinician Programmer Application (PPA) Software (Version 4.0) • Model A620 Patient Programmer Application (CPA) (Version 3.0) • A90300 Recharger Application Software (RAS) (Version 2.0) • Dystonia Kits (Models 33TH60, 33TH76, and 33TH69) • Labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new Percept RC System.For H050003/S289, approval for:• Model A610 Clinician Programmer Application (PPA) Software (Version 4.0) For P840001/S527, approval for: • Labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new Percept RC System
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