FDA.reportPublic FDA data

PMA P030017S344

Device
Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi Spinal Cord Stimulator (SCS) System, Precision Mon
Applicant
Boston Scientific Corp
Product code
LGW
Decision date
2021-07-12
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order 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.

Current openFDA PMA Record#

Device
Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi Spinal Cord Stimulator (SCS) System, Precision Mon
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S344
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-07-12
Decision code
APPR
Date received
2021-04-19
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order 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.