|
Device | Precision Spectra WaveWriter Spinal Cord Stimulator Systems, Precision Spectra, Pre-Weld Test Equipment 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 | S312 |
Date Received | 03/12/2018 |
Decision Date | 04/02/2018 |
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 pre-weld test equipment software used for testing the Precision Spectra and Precision Spectra Wavewriter implanted pulse generators (IPG). The update is to remove two tests (biphasic stimulation test and electrode isolation test) that duplicate upstream and downstream testing performed on the IPG. |