FDA.reportPublic FDA data

PMA P030017S343

Device
Precision Spinal Cord Stimulator (SCS) Systems
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S343
Product code
LGW
Decision date
2021-04-23
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
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).

Current openFDA PMA Record#

Device
Precision Spinal Cord Stimulator (SCS) Systems
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S343
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-04-23
Decision code
OK30
Date received
2021-04-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
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).