PMA P960009S428

Device: Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S428
Product code: MHY
Decision date: 2022-05-24
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Change the testing of the M960543A Stim Integrated Circuit and the M960545A Multi-Function Integrated Circuit wafer products from the LTX to the SPEA Compact Automated Test Equipment at the Medtronic Tempe Campus.

Current openFDA PMA Record#

Device: Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S428
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2022-05-24
Decision code: OK30
Date received: 2022-05-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change the testing of the M960543A Stim Integrated Circuit and the M960545A Multi-Function Integrated Circuit wafer products from the LTX to the SPEA Compact Automated Test Equipment at the Medtronic Tempe Campus.