FDA.reportPublic FDA data

PMA P030017S348

Device
WaveWriter Alpha™ Spinal Cord Stimulator (SCS) System
Applicant
Boston Scientific Corp
Product code
LGW
Decision date
2021-11-10
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
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.

Current openFDA PMA Record#

Device
WaveWriter Alpha™ Spinal Cord Stimulator (SCS) System
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S348
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-11-10
Decision code
OK30
Date received
2021-10-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.