Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense

FDA premarket approval P960009/S498 · decided 2024-12-23

Approval details

PMA number

P960009

Supplement

S498

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

Medtronic, Inc.

Date received

2024-12-09

Decision date

2024-12-23

Days to decision

14 days

Decision code

OK30

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Minneapolis, MN

Statement

approval for manufacturing updates of metal strip resistors manufactured at Vishay Thin Film, an external supplier to Medtronic’s internal supplier – Medtronic Tempe Campus (MTC). The supplier requested updates include use of an existing sample preparation method, and a tolerance change on a negligible risk level feature for manufacturability

510(k) clearances by this applicant