PMA P840001S522

Device: Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spinal Cord S
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S522
Product code: LGW
Decision date: 2022-07-28
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Change to the Ionograph Out-of-Control Action Plan (OCAP) and the test sampling plan within the Final Clean process for hybrids manufactured at Medtronic Tempe Campus (MTC).

Current openFDA PMA Record#

Device: Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spinal Cord S
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S522
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-07-28
Decision code: OK30
Date received: 2022-07-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the Ionograph Out-of-Control Action Plan (OCAP) and the test sampling plan within the Final Clean process for hybrids manufactured at Medtronic Tempe Campus (MTC).