|
Device | Precision Spinal Cord Stimulator (SCS) System, Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Noviâ„¢ |
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 | S335 |
Date Received | 03/27/2020 |
Decision Date | 04/24/2020 |
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 Addition of an additional ethylene oxide (EO) sterilization chamber and associated sterilization process located at Boston Scientific Dorado Manufacturing site (BSC-DOR). |