PMA P960009S410

Device: SenSight™ Extension Kit
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S410
Product code: MHY
Decision date: 2021-10-27
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Changes to the Proximal Body Assembly (PBA), which includes increasing the PBA core pin outer diameter tolerance and allowing replacement of PBA tensile test samples when there is a tubing break below the required acceptance criteria, for the SenSight Directional Lead System (Octave) extension subassemblies at the Medtronic Danvers, MA facility.

Current openFDA PMA Record#

Device: SenSight™ Extension Kit
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S410
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2021-10-27
Decision code: OK30
Date received: 2021-09-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the Proximal Body Assembly (PBA), which includes increasing the PBA core pin outer diameter tolerance and allowing replacement of PBA tensile test samples when there is a tubing break below the required acceptance criteria, for the SenSight Directional Lead System (Octave) extension subassemblies at the Medtronic Danvers, MA facility.