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. |
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Device | Percision, Precision Spectra, Spectra WaveWriter; Precision Novi, Percision Montage and Percision Montage MRI Spinal Co |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Boston Scientific Corp. 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P030017 |
Supplement Number | S331 |
Date Received | 10/28/2019 |
Decision Date | 01/24/2020 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updating the Clinician Programmer (CP) computer to Surface Pro (SP6) with Windows 10 and for minor installation and labeling updates to the Bionic Navigator software used with the Precision, Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, and Precision Montage MRI Spinal Cord Stimulator (SCS) Systems. |
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