- Device
- Master Activa®, Percept and SenSight Deep Brain Stimulation Therapy System
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S438
- Product code
- MBX
- Generic name
- Stimulator, thalamic, epilepsy, implanted
- Decision date
- 2024-01-08
- Decision code
- APPR
- Date received
- 2022-08-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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