Liberta RC DBS IPG ,Charger Kit - Pectoral ,Patient Controller Application ,Clinician Programmer Application

FDA premarket approval P010032/S202 · decided 2024-01-24

Approval details

PMA number

P010032

Supplement

S202

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

Liberta RC DBS IPG ,Charger Kit - Pectoral ,Patient Controller Application ,Clinician Programmer Application

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2023-07-28

Decision date

2024-01-24

Days to decision

180 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

For P140009/S087, approval for:• The Liberta RCTM DBS System, including the Liberta RC DBS IPG (model 62400) and Charger Kit – Pectoral (model 66000)• Patient Controller Application version 2.0 and Clinician Programmer Application version 2.0 including the NeuroshpereTM Virtual Clinic • Alternate resistor component changes in the printed circuit board assembly (PCBA) for the Liberta RC DBS IPG (model 62400)• An alternate cell battery part number from an existing supplier for Charger Model 16000

510(k) clearances by this applicant