PMA P840001S516

Device: Itrel, Synergy, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify, and Vectris Spinal Cord St
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S516
Product code: LGW
Decision date: 2022-05-12
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Changes to the final acceptance procedures for hybrid modules and assemblies and the hybrid final pack and bag RFID process specifications procedures to correct identified gaps in standard work as determined during a CAPA investigation.

Current openFDA PMA Record#

Device: Itrel, Synergy, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify, and Vectris Spinal Cord St
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S516
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-05-12
Decision code: OK30
Date received: 2022-05-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the final acceptance procedures for hybrid modules and assemblies and the hybrid final pack and bag RFID process specifications procedures to correct identified gaps in standard work as determined during a CAPA investigation.