PMA P840001S243
- Device
- SPINAL CORD STIMULATION (SCS) NEUROSTIMULATORS IMPLANTABLE (INS) RESTORE FAMILY
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S243
- Product code
- LGW
- Decision date
- 2013-08-02
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- CHANGES WITHIN THE RESTORESMALL BATTERY BURN-IN AND INSPECTION PROCESS.
Current openFDA PMA Record#
- Device
- SPINAL CORD STIMULATION (SCS) NEUROSTIMULATORS IMPLANTABLE (INS) RESTORE FAMILY
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S243
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2013-08-02
- Decision code
- OK30
- Date received
- 2013-07-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES WITHIN THE RESTORESMALL BATTERY BURN-IN AND INSPECTION PROCESS.