FDA.reportPublic FDA data

PMA P030017S347

Device
Wave Writer Alpha TM Spinal Cord Stimulator (SCS) System
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S347
Product code
LGW
Decision date
2021-10-07
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
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.

Current openFDA PMA Record#

Device
Wave Writer Alpha TM Spinal Cord Stimulator (SCS) System
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S347
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-10-07
Decision code
OK30
Date received
2021-09-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.