- Device
- Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S472
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2020-11-12
- Decision code
- OK30
- Date received
- 2020-10-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction in nonviable air sampling to comply with ISO 14644:2015-1.