|
Device | Wave Writer Alpha TM Spinal Cord Stimulator (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 | S347 |
Date Received | 09/13/2021 |
Decision Date | 10/07/2021 |
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 Update to the Implantable Pulse Generator (IPG) Automatic Test Equipment (ATE) software to widen the acceptance criteria limits during the (PCBA) manufacturing process. |