FDA.reportPublic FDA data

PMA P840001S453

Device
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea
Applicant
Medtronic Neuromodulation
PMA number
P840001
Supplement
S453
Product code
LGW
Decision date
2020-02-05
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Change in the destructive testing pull test sampling, sampling frequency, and tightening of the control limits established for the pull test monitoring.

Current openFDA PMA Record#

Device
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea
Applicant
Medtronic Neuromodulation
PMA number
P840001
Supplement
S453
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2020-02-05
Decision code
OK30
Date received
2020-01-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in the destructive testing pull test sampling, sampling frequency, and tightening of the control limits established for the pull test monitoring.