PMA P030017S315
- Device
- Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI an Spectra WaveWriter SPinal Cord Stimulator
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S315
- Product code
- LGW
- Decision date
- 2018-08-01
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Removal of the weekly Printed Circuit Board Assembly (PCBA) Ionic Contamination (IC) Testing on the Archie, Montana, and Spectra circuit boards which are used in the Implantable Pulse Generators (IPGs) for the Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cord Stimulator (SCS) Systems.
Current openFDA PMA Record#
- Device
- Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI an Spectra WaveWriter SPinal Cord Stimulator
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S315
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2018-08-01
- Decision code
- OK30
- Date received
- 2018-07-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of the weekly Printed Circuit Board Assembly (PCBA) Ionic Contamination (IC) Testing on the Archie, Montana, and Spectra circuit boards which are used in the Implantable Pulse Generators (IPGs) for the Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cord Stimulator (SCS) Systems.