|
Device | Precision Spinal Cord Stimulator (SCS) Systems |
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 | S343 |
Date Received | 04/19/2021 |
Decision Date | 04/23/2021 |
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 two new reflow ovens to the manufacturing process for the Printed Circuit Board Assemblies (PCBAs) of the Implantable Pulse Generator (IPG) and External Trial Stimulator (ETS). |