- Device
- Liberta RC DBS IPG ,Charger Kit - Pectoral ,Patient Controller Application ,Clinician Programmer Application
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140009
- Supplement
- S087
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2024-01-24
- Decision code
- APPR
- Date received
- 2023-07-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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 when used with the Liberta RC DBS SystemFor P010032/S202, approval for: Patient Controller Application version 2.0 and Clinician Programmer Application version 2.0 including the NeuroshpereTM Virtual Clinic and FlexBurst360TM programming Change the requirement regarding MRI mode during charging in the Eterna SCS System to align with the Liberta RC DBS System