- Device
- Vanta™with AdaptiveStim™ Technology - Model 977006
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S634
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-09-24
- Decision code
- OK30
- Date received
- 2026-08-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for implementation of a manufacturing process change that will update the manufacturing execution system flow for the affected feedthrough product family