|
Device | PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) 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 | S273 |
Date Received | 12/19/2016 |
Decision Date | 05/12/2017 |
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 Spectra IPG. The current flash memory component is no longer available and needs to be replaced. The change will replace the current flash memory component with a new flash memory component from the same supplier. The functionality of the IPG is unchanged. |