PMA P840001S517

Device: Master Vanta Spinal Cord Stimulation Systems
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S517
Product code: LGW
Decision date: 2022-05-24
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Change the testing of the M960543A Stim Integrated Circuit and the M960545A Multi-Function Integrated Circuit wafer products from the LTX to the SPEA Compact Automated Test Equipment at the Medtronic Tempe Campus.

Current openFDA PMA Record#

Device: Master Vanta Spinal Cord Stimulation Systems
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S517
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-05-24
Decision code: OK30
Date received: 2022-05-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change the testing of the M960543A Stim Integrated Circuit and the M960545A Multi-Function Integrated Circuit wafer products from the LTX to the SPEA Compact Automated Test Equipment at the Medtronic Tempe Campus.