FDA-approved Abbott spinal cord stimulation family (Prodigy, Proclaim XR, Proclaim Plus, Externa), indications expanded to diabetic neuropathy and non-surgical back pain in 2023. Thin: hardware specs not in the FDA summary read.
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 Proclaim XR spinal cord stimulation
Abbott’s SCS family is approved under PMA P010032 and delivers epidural stimulation from a rechargeable or non-rechargeable IPG. This sheet uses the FDA summary for supplement S189 and the S191 record. Hardware specs and trial numbers are Unreported because the FDA text read does not give them.
Identity
Field
Value and source scope
Device
Abbott Spinal Cord Stimulation Systems (Prodigy, Proclaim, Proclaim XR, Proclaim Plus, Externa): external pulse generator, implantable pulse generator, leads and extensions, clinician programmer, patient programmer and patient recharger [1][2]
Manufacturer
Abbott Medical, Plano, Texas [1]
Interface class
Epidural spinal cord stimulation leads with a subcutaneous IPG [1]
Origin
Commercial FDA-approved device; PMA P010032, original approval December 3, 2001 [1]
First demonstrated
Unreported
First human implant
Unreported
Species studied
Human [1]
Regulatory status
P010032/S189 (diabetic peripheral neuropathy of the lower extremities) notice of approval January 24, 2023; S191 (Prodigy, Proclaim XR, Proclaim Plus and Externa) decision May 10, 2023, adding non-surgical back pain for tonic and BurstDR modes and DPN for tonic mode [1][2]
Function
Aid in the management of chronic, intractable pain of the trunk and/or limbs [1]
Target tissue
Spinal cord, epidural space [1]
Geometry and architecture
Field
Value and source scope
Interface type
Permanent and trial leads in multiple configurations with variable lead body lengths and electrode spacing; extensions connect lead to neurostimulator [1]
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
IPG in a hermetically sealed titanium case with an integrated circuit; subcutaneous pocket; programmed by an external Patient Programmer [1]
Data path
Unreported
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Rechargeable IPG models use a patient recharger charged by a plug-in charger [1]
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
Chronic intractable pain of the trunk and/or limbs, including failed back surgery syndrome, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities (S189 wording) [1]
Trials and registries
S189 rested mainly on a systematic review of the published literature (1984-2022), two randomized controlled trials in diabetic peripheral neuropathy and Medicare claims data [1]
Primary outcomes
Unreported
Key limitations
The SSED text read gives no lead contact counts, IPG dimensions, battery figures or trial numbers; those read Unreported. Systems covered by one PMA span several generations; this sheet follows the Proclaim family as named in S191 [1][2]
Engineering tradeoffs
Field
Value and source scope
Strengths
Unreported
Limitations
Unreported
Scaling constraints
Unreported
Version boundary
S191 (decision May 10, 2023) is the latest supplement record read, naming Prodigy, Proclaim XR, Proclaim Plus and Externa. Later supplements were not reviewed.