|
Device | Precision Montage and Precision Montage MRI Spinal Cord Stimulator 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 | S293 |
Date Received | 05/23/2017 |
Decision Date | 06/21/2017 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Update to the Montage and Montage MRI IPG Automated Test Equipment (ATE) device level test software to address elevated noise levels during stimulation timing testing which may affect communication between the test computer and device being tested. |