FDA.reportPublic FDA data

PMA P030017S359

Device
Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, and WaveWriter Alpha Sp
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S359
Product code
LGW
Decision date
2023-01-04
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Use existing equipment at the BSC Dorado facility to perform the laser ablation on the multi-lumen tubes used in the assembly of the D4 and W4 2x4 Splitters, 2x8 Splitters, and M1 Connectors used in the SCS Systems.

Current openFDA PMA Record#

Device
Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, and WaveWriter Alpha Sp
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S359
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2023-01-04
Decision code
OK30
Date received
2022-12-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use existing equipment at the BSC Dorado facility to perform the laser ablation on the multi-lumen tubes used in the assembly of the D4 and W4 2x4 Splitters, 2x8 Splitters, and M1 Connectors used in the SCS Systems.