Liberta RC DBS Charging System
FDA premarket approval P140009/S106 · decided 2024-11-13
Approval details
- PMA number
- P140009
- Supplement
- S106
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Liberta RC DBS Charging System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-09-03
- Decision date
- 2024-11-13
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Your supplement requested approval for a minor packaging and labeling change introducing the SCS Model 36700 SCS Charging system and the Model 66700 and DBS Charging system.
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