PMA P840001S496

Device: Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S496
Product code: LGW
Decision date: 2021-08-13
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Change to the welding process and equipment at external supplier, Bal Seal Engineering (BSE), who supplies Radial Spring Contacts to Medtronic Energy and Component Center (MECC).

Current openFDA PMA Record#

Device: Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S496
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2021-08-13
Decision code: OK30
Date received: 2021-07-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the welding process and equipment at external supplier, Bal Seal Engineering (BSE), who supplies Radial Spring Contacts to Medtronic Energy and Component Center (MECC).