|
Device | Precision Spectra Spinal Cord Stimulator (SCS) System |
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 | S306 |
Date Received | 11/02/2017 |
Decision Date | 01/31/2018 |
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 a modification of the Precision Spectra Implantable Pulse Generator (IPG) firmware to adjust temperature sensor calibration with an aim to improve the accuracy of the sensor reading. |