PMA P030017S275
- Device
- PrecisionTM and Spectra WaveWriterTM Spinal Cord Stimulation (SCS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S275
- Product code
- LGW
- Decision date
- 2017-08-11
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for expanding indications to include Complex Regional Pain Syndrome (CRPS) Types I and II and the following associated conditions and etiologies: radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, and multiple back surgeries.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030017S275B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- PrecisionTM and Spectra WaveWriterTM Spinal Cord Stimulation (SCS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S275
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2017-08-11
- Decision code
- APPR
- Date received
- 2016-12-27
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for expanding indications to include Complex Regional Pain Syndrome (CRPS) Types I and II and the following associated conditions and etiologies: radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, and multiple back surgeries.