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. |
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Device | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S443 |
Date Received | 11/14/2022 |
Decision Date | 11/22/2022 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Separation of a manufacturing process, Bond Pad Array (EPA) Lid Removal, as a standalone process for better tracking at internal supplier Medtronic Tempe Campus (MTC); and the addition of a videoscope manufacturing equipment for improved process controls. |
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