PMA P840001S468

Device: Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
Applicant: Medtronic Neuromodulation
Product code: LGW
Decision date: 2020-11-03
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval to add the use of tin-lead plating for the terminations of both ends of the T8 tantalum capacitors and for the Model 97810 InterStim Micro INS only, change the solder paste stencil tooling for the 1411 capacitor size to increase the amount of solder paste to match the mount used on other capacitor case sizes.

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: S468
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2020-11-03
Decision code: APPR
Date received: 2020-08-21
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to add the use of tin-lead plating for the terminations of both ends of the T8 tantalum capacitors and for the Model 97810 InterStim Micro INS only, change the solder paste stencil tooling for the 1411 capacitor size to increase the amount of solder paste to match the mount used on other capacitor case sizes.