FDA-approved rechargeable DBS system from Abbott, approved by supplement S087 of PMA P140009 in January 2024. Many fields stay Unreported because the FDA record and company pages do not give them.
Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.
Abbott Liberta RC DBS system
The Liberta RC is Abbott’s rechargeable DBS pulse generator, approved under PMA P140009 supplement S087 with a decision date of January 24, 2024. This is the thinnest-sourced of the DBS sheets: the FDA supplement record gives model numbers and software versions, and Abbott’s page adds charging claims. Unknown values stay Unreported.
Rechargeable deep brain stimulation implantable pulse generator for use with Abbott DBS leads [1][2]
Origin
Commercial FDA-approved device within PMA P140009 [1]
First demonstrated
Unreported
First human implant
Unreported
Species studied
Unreported
Regulatory status
PMA P140009/S087 decision date January 24, 2024: approval of the Liberta RC system, model 62400 IPG and model 66000 charger kit [1]
Function
Rechargeable stimulation of deep brain targets for parkinsonian tremor per the FDA generic name [1]
Target tissue
Unreported in the FDA record read here; product generic name is stimulator, electrical, implanted, for parkinsonian tremor [1]
Geometry and architecture
Field
Value and source scope
Interface type
Unreported
Array layout
Unreported
Electrode count
Unreported
Pitch
Unreported
Electrode lengths
Unreported
Shank width and thickness
Unreported
Tip and exposed site geometry
Unreported
Contact coating
Unreported
Insulation
Unreported
Insertion method
Unreported
Anchoring and fixation
Unreported
Electrode and channel physics
Field
Value and source scope
Exposed site area
Unreported
Electrode material
Unreported
Impedance (with measurement frequency)
Unreported
Noise floor or SNR
Unreported
Recording modality
Unreported
Sampling rate
Unreported
Stimulation capability
Unreported
Charge injection limit
Unreported
Reference and ground
Unreported
Tissue interface and bioresponse
Field
Value and source scope
Target tissue
Unreported
Insertion trauma and BBB disruption
Unreported
Vascular disruption risk
Unreported
Micromotion sensitivity
Unreported
Gliosis and encapsulation
Unreported
Neuron loss near sites
Unreported
Foreign-body response mitigation
Unreported
Typical failure modes
Unreported
System architecture
Field
Value and source scope
Onboard electronics
Rechargeable-cell IPG with wireless charging and updated Bluetooth; also an alternate resistor component in the printed circuit board assembly [1][2]
Data path
Bluetooth to a clinician programmer with an iOS interface; NeuroSphere Virtual Clinic remote programming [1][2]
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Rechargeable cell; Abbott states a charging frequency of 10 times per year (manufacturer claim). The charger holds two full IPG charges and has an alternate cell battery part number from an existing supplier [1][2]
Thermal management
Unreported
Packaging and hermeticity
Unreported
MRI compatibility
Unreported
Surgical complexity
Unreported
Output connectors
Unreported
Performance envelope
Field
Value and source scope
Acute yield
Unreported
Chronic yield
Unreported
Stability over time
Unreported
Longevity
Unreported
Revision and explant experience
Unreported
Adverse events
Unreported
Notable demonstrations
Unreported
Clinical and preclinical evidence
Field
Value and source scope
Human subjects
Unreported
Preclinical cohort
Unreported
Follow-up duration
Unreported
Indications
Unreported
Trials and registries
Unreported; S087 is a normal 180-day supplement for design, components, specifications and material changes [1]
Primary outcomes
Unreported
Key limitations
This sheet rests on the FDA supplement record and Abbott marketing pages. Lead geometry, sensing and clinical data were not located in a primary Abbott or FDA document [1][2]
Engineering tradeoffs
Field
Value and source scope
Strengths
Abbott states the lowest recharge frequency and smallest implant profile among rechargeable DBS IPGs it compared (manufacturer comparative claim, not independently verified) [2]
Limitations
Requires patient recharging [2]
Scaling constraints
Unreported
Version boundary
The sheet covers the Liberta RC IPG (model 62400) and charger kit (model 66000) named in S087. Earlier Infinity IPGs in the same PMA family, and the Abbott DBS leads, are not described here. The S087 order statement also covers a separate Abbott spinal cord stimulation PMA (P010032/S202) for software and MRI-mode changes, which is outside this sheet.