PMA P030017S312
- Device
- Precision Spectra WaveWriter Spinal Cord Stimulator Systems, Precision Spectra, Pre-Weld Test Equipment System
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S312
- Product code
- LGW
- Decision date
- 2018-04-02
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Update to the pre-weld test equipment software used for testing the Precision Spectra and Precision Spectra Wavewriter implanted pulse generators (IPG). The update is to remove two tests (biphasic stimulation test and electrode isolation test) that duplicate upstream and downstream testing performed on the IPG.
Current openFDA PMA Record#
- Device
- Precision Spectra WaveWriter Spinal Cord Stimulator Systems, Precision Spectra, Pre-Weld Test Equipment System
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S312
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2018-04-02
- Decision code
- OK30
- Date received
- 2018-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the pre-weld test equipment software used for testing the Precision Spectra and Precision Spectra Wavewriter implanted pulse generators (IPG). The update is to remove two tests (biphasic stimulation test and electrode isolation test) that duplicate upstream and downstream testing performed on the IPG.