PMA P840001S191
- Device
- RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S191
- Product code
- LGW
- Decision date
- 2011-07-29
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- PROCEDURE MODIFICATION TO MEET THE REQUIREMENTS OF UPDATED INDUSTRY STANDARDS.
Current openFDA PMA Record#
- Device
- RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S191
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2011-07-29
- Decision code
- OK30
- Date received
- 2011-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- PROCEDURE MODIFICATION TO MEET THE REQUIREMENTS OF UPDATED INDUSTRY STANDARDS.