Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Basic Information
- Device Name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Trade Name
- Spinal Cord Stimulation (SCS)
- PMA Number
- P010032
- Supplement Number
- S172
- Device Class
- FDA Class 3
- Product Code
- LGW
- Generic Name
- Stimulator, spinal-cord, totally implanted for pain relief
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 26, 2021
- Date Received
- February 12, 2021
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the replacement of the supplier for the Thermal Cutoff (TCO) component used in the lithium ion (Li-Ion) Rechargeable Battery Pack used to recharge Implanted Pulse Generator (IPG), and for a design change to the TCO component of the Battery Pack. The design change includes the addition of a bottom metal strap to the TCO component, different dimensions of the Battery Pack due to the thicker new TCO component, an increased current allowance from 2 Amps to 7 Amps, lower voltage cutoff from 32 Volts to 28 Volts, and a lower temperature cutoff of from 92C to 82C. This change is implemented to the following specific Chargers: 3720 Eon Mini LE Charger, 3722 Eon Mini LE Charging System, 3727 Eon Charger, 3726 Eon Charging System, 3730 Prodigy Charging System, 6720 Brio LE Charger, 6722 Brio LE Charging System.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | FDA class 3 | Unknown |