- Device
- Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S450
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2020-06-25
- Decision code
- APPR
- Date received
- 2019-12-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the new WR9200 Wireless Recharger Subsystem and associated labeling. The new WR9200 Wireless Recharger Subsystem is intended to recharge the Activa RC implantable neurostimulator (INS) for Deep Brain Stimulation Therapy and the following Restore INSs for Spinal Cord Stimulation Therapy: RestoreUltra; RestoreUltra SureScan MRI; RestoreSensor; and RestoreSensor SureScan MRI.