|
Device | Precision Montage MRI and Precision Montage Spinal Cord Stimulator (SCS)Systems |
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 | S281 |
Date Received | 02/08/2017 |
Decision Date | 05/08/2017 |
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 an update to the flash memory component used on the PCBA in the Precision Montage IPG. |