- Device
- Restore and Itrel® Spinal Cord Stimulation Systems
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S536
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2023-02-02
- Decision code
- OK30
- Date received
- 2023-01-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement manufacturing process changes at an external supplier in order to manufacturing different sized TBC series tantalum capacitors.