|
Device | Spectra WaveWriter 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 | S305 |
Date Received | 11/01/2017 |
Decision Date | 12/01/2017 |
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 the test equipment system software (to add 40 seconds delay between the Bootloader and application firmware download tests) used for testing the 'Spectra Wave Writer (SCS) External Trial Stimulator (ETS) units. |