FDA.reportPublic FDA data

PMA P030017S323

Device
Precision Spinal Cord Stimulator (SCS) Systems -Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage
Applicant
Boston Scientific Corp
Product code
LGW
Decision date
2019-05-14
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Approval to activate the on-board Bluetooth (BLE) functionality of your Freelink RC4 remote control device. The activation of the BLE is for data transmission from the Freelink RC4 to an application on a non-medical mobile device for the purpose of data logging.

Current openFDA PMA Record#

Device
Precision Spinal Cord Stimulator (SCS) Systems -Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S323
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2019-05-14
Decision code
APPR
Date received
2019-02-12
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to activate the on-board Bluetooth (BLE) functionality of your Freelink RC4 remote control device. The activation of the BLE is for data transmission from the Freelink RC4 to an application on a non-medical mobile device for the purpose of data logging.