PMA P960009S413

Device: Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S413
Product code: MHY
Decision date: 2021-12-03
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Replacement of current Underfill Dispense System (Asymtek Axiom X-1020) with a new system (Asymtek Spectrum II) at Medtronic Tempe Campus (MTC).

Current openFDA PMA Record#

Device: Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S413
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2021-12-03
Decision code: OK30
Date received: 2021-11-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of current Underfill Dispense System (Asymtek Axiom X-1020) with a new system (Asymtek Spectrum II) at Medtronic Tempe Campus (MTC).