PMA P030017S308
- Device
- Precision Montage MRI Spinal Cord Stimulator System
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S308
- Product code
- LGW
- Decision date
- 2018-03-12
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for an update to the Precision Montage and Precision Montage MRI Spinal Cord Stimulator (SCS) System firmware to adjust the temperature sensor calibration with an aim to improve the accuracy of the sensor reading, associated changes to the Printed Circuit Board Assembly and device level Automated Test Equipment software, and rework of the IPG devices that failed the device level temperature sensor test.
Current openFDA PMA Record#
- Device
- Precision Montage MRI Spinal Cord Stimulator System
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S308
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2018-03-12
- Decision code
- APPR
- Date received
- 2017-12-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an update to the Precision Montage and Precision Montage MRI Spinal Cord Stimulator (SCS) System firmware to adjust the temperature sensor calibration with an aim to improve the accuracy of the sensor reading, associated changes to the Printed Circuit Board Assembly and device level Automated Test Equipment software, and rework of the IPG devices that failed the device level temperature sensor test.