- Device
- Liberta RC™ DBS IPG
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140009
- Supplement
- S092
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2024-05-02
- Decision code
- APPR
- Date received
- 2024-02-05
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for the standardization of the presentation of dimensions of the Liberta RC DBS IPG (model 62400) and the Eterna SCS IPG (model 32400) within device labeling, basing them on nominal specification values via a computer-generated engineering model