PMA P030017S297
- Device
- Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S297
- Product code
- LGW
- Decision date
- 2017-12-21
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for labeling changes associated with the demonstrated safety and effectiveness of subperception therapy.
Current openFDA PMA Record#
- Device
- Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S297
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2017-12-21
- Decision code
- APPR
- Date received
- 2017-06-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes associated with the demonstrated safety and effectiveness of subperception therapy.