- Device
- Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S492
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2021-07-21
- Decision code
- OK30
- Date received
- 2021-06-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to battery processing and other related minor manufacturing updates at Medtronic’s internal supplier, Medtronic Energy Component Center.