PMA P970004

Device: InterStim™ Therapy System, Verify™ Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S378
Product code: EZW
Decision date: 2026-10-09
Generic name: Stimulator, electrical, implantable, for incontinence
Approval order statement: approval for the introduction of a second Medium Rate (MR) Header’s manufacturing line (MR Line 2) and to make inspection updates to the MR Headers Line that is currently in production at Medtronic Energy and Components Center (MECC), Brooklyn Center, MN.

Current openFDA PMA Record#

Device: InterStim™ Therapy System, Verify™ Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S459
Product code: EZW
Generic name: Stimulator, electrical, implantable, for incontinence
Decision date: 2026-10-09
Decision code: OK30
Date received: 2026-09-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the introduction of a second Medium Rate (MR) Header’s manufacturing line (MR Line 2) and to make inspection updates to the MR Headers Line that is currently in production at Medtronic Energy and Components Center (MECC), Brooklyn Center, MN.