Precision Montage MRI Spinal Cord Stimulator System
FDA premarket approval P030017/S308 · decided 2018-03-12
Approval details
- PMA number
- P030017
- Supplement
- S308
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Precision Montage MRI Spinal Cord Stimulator System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2017-12-12
- Decision date
- 2018-03-12
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- 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.
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