PMA P840001S520

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: S520
Product code: LGW
Decision date: 2022-06-01
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Change to a vapor degreaser rework implementation and process improvements at Medtronics internal supplier, Medtronic Tempe Campus.

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: S520
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-06-01
Decision code: OK30
Date received: 2022-05-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to a vapor degreaser rework implementation and process improvements at Medtronics internal supplier, Medtronic Tempe Campus.