- Device
- Master Restore, Itrel®, Synergy® and Intellis™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spina
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S504
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2021-12-15
- Decision code
- OK30
- Date received
- 2021-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Revision to the manufacturing execution system used in several facilities for the subject devices.