Percept™ PC INS with BrainSense™ (Model B35200)

FDA premarket approval P960009/S445 · decided 2023-09-22

Approval details

PMA number

P960009

Supplement

S445

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

Percept™ PC INS with BrainSense™ (Model B35200)

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

Medtronic, Inc.

Date received

2022-12-22

Decision date

2023-09-22

Days to decision

274 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Minneapolis, MN

Statement

Approval for adding a new requirement and new behavior to the firmware and changing the `Stim off Charge Pump Amplitude' from the maximum value to the minimum value. When stimulation is off, the Charge Pump will be set to the minimum value. Adding a new risk control measure and new behavior to the firmware. Every 5 minutes the firmware will now reset the Tel-N Phase Lock Loop (PLL). The interface and requirement will also be changed, and new behavior will be added to the firmware. When the relev

510(k) clearances by this applicant