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Device | Precision Novi Spinal Cord Stimulator (SCS) System Flash Memory Component Update |
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 | S307 |
Date Received | 11/09/2017 |
Decision Date | 02/05/2018 |
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 to replace the flash memory component used on the Printed Circuit Board Assembly (PCBA) with the Precision Novi Implantable Pulse Generator (IPG). |