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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePrecision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi Spinal Cord Stimulator (SCS) System, Precision Mon
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp.
25155 rye canyon loop
valencia, CA 91355
PMA NumberP030017
Supplement NumberS344
Date Received04/19/2021
Decision Date07/12/2021
Product Code LGW 
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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.
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