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PMA P840001S483

Device
Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® Spinal Cord Stimulati
Applicant
Medtronic Neuromodulation
PMA number
P840001
Supplement
S483
Product code
LGW
Decision date
2021-02-10
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Manufacturing location change of polymer resin for an external supplier, AGC Chemicals, and change in a processing aid used in the production of ETFE due to the environmental regulations.

Current openFDA PMA Record#

Device
Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® Spinal Cord Stimulati
Applicant
Medtronic Neuromodulation
PMA number
P840001
Supplement
S483
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-02-10
Decision code
OK30
Date received
2021-01-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacturing location change of polymer resin for an external supplier, AGC Chemicals, and change in a processing aid used in the production of ETFE due to the environmental regulations.