FDA.reportPublic FDA data

PMA P840001S490

Device
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
Applicant
Medtronic Neuromodulation
PMA number
P840001
Supplement
S490
Product code
LGW
Decision date
2021-06-25
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Newly defined and characterized solder paste inspection (SPI) process at Medtronic Tempe Campus (MTC), Medtronic’s internal supplier of hybrids used in the manufacturing of Medtronic Neuromodulation (Neuro) products.

Current openFDA PMA Record#

Device
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
Applicant
Medtronic Neuromodulation
PMA number
P840001
Supplement
S490
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-06-25
Decision code
OK30
Date received
2021-05-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Newly defined and characterized solder paste inspection (SPI) process at Medtronic Tempe Campus (MTC), Medtronic’s internal supplier of hybrids used in the manufacturing of Medtronic Neuromodulation (Neuro) products.