Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Basic Information
- Device Name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Trade Name
- Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi Spinal Cord Stimulator (SCS) System, Precision Mon
- PMA Number
- P030017
- Supplement Number
- S344
- 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 12, 2021
- Date Received
- April 19, 2021
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for an update to the existing Software Bionic Navigator 3D version 4.0 to version 4.1. The updated software will be installed on the Clinician Programmer using the Bionic Navigator (BN) 3D 4.1 Installer (Model # SC-7101-410). This would allow one single software version (BN3D 4.1) to support all the Precision Spectra, Precision Novi, Precision Montage MRI, and Spectra WaveWriter and WaveWriter Alpha BCS Stimulators. The user interface of BN 3D 4.1 remain the same except for translations into various languages to support the international markets. In addition, BN 3D 4.1 introduces a new Sequence feature for additional flexibility when programming WaveWriter Alpha stimulators, in which a Sequence composed of various blocks of pulses can be created using a Composer tool and applied to the stimulators in a Programming Mode called Sequence Mode.The BN 3D software will be updated to Version 4.1 so that one single software version (BN3D 4.1) can support all the Precision Spectra, Precision Novi, Precision Montage MRI, and Spectra WaveWriter and WaveWriter Alpha BCS Stimulators. The user interface of BN 3D 4.1 will remain the same except for translations into various languages to support the international markets. In addition, BN 3D 4.1 introduces a new Sequence feature for additional flexibility when programming WaveWriter Alpha stimulators, in which a Sequence composed of various blocks of pulses can be created using a Composer tool and applied to the stimulators in a Programming Mode called Sequence Mode. Note that the new Sequence feature is only applicable to WaveWriter Alpha stimulators. The existing programming features for all stimulators remain the same.
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 |