|
Device | WaveWriter Alpha™ 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 | S348 |
Date Received | 10/12/2021 |
Decision Date | 11/10/2021 |
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 Use VLSIP Technologies as an alternate supplier for the Ball Grid Array (BGA), an electronic component on the Printed Circuit Board Assembly (PCBA) of the Implantable Pulse Generators (IPG) and External Trial Stimulators (ETS) of the WaveWriter Alpha Spinal Cord Stimulator (SCS) System and Vercise Genus Deep Brain Stimulation (DBS) System. |