PMA P840001S487

Device: Itrel®, Synergy® and lntellisTM Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris®
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S487
Product code: LGW
Decision date: 2021-05-06
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Use of an alternate component supplier Meier Tool & Engineering, Inc. for the platinum iridium electrodes used in SCS Leads, Models 39286, 39565, 977C165, 977C190, 977C265, & 977C290. Meier Tool & Engineering, Inc. will form the electrodes using progressive die instead of manual blank/form die. Vanishing Oil 101 will be used in the manufacturing process. Meier Tool & Engineering, Inc. will SQM Inspect the product and Medtronic Villalba will SQM Verify the product.

Current openFDA PMA Record#

Device: Itrel®, Synergy® and lntellisTM Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris®
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S487
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2021-05-06
Decision code: OK30
Date received: 2021-04-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Use of an alternate component supplier Meier Tool & Engineering, Inc. for the platinum iridium electrodes used in SCS Leads, Models 39286, 39565, 977C165, 977C190, 977C265, & 977C290. Meier Tool & Engineering, Inc. will form the electrodes using progressive die instead of manual blank/form die. Vanishing Oil 101 will be used in the manufacturing process. Meier Tool & Engineering, Inc. will SQM Inspect the product and Medtronic Villalba will SQM Verify the product.