PMA P080025S268

Device: InterStim® Therapy System, Verify® Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S268
Product code: QON
Decision date: 2022-09-13
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Replacement of inspection equipment at external supplier Innovize, Inc., for the inspection of components used at the Medtronic Energy and Component Center (MECC) site.

Current openFDA PMA Record#

Device: InterStim® Therapy System, Verify® Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S268
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2022-09-13
Decision code: OK30
Date received: 2022-08-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of inspection equipment at external supplier Innovize, Inc., for the inspection of components used at the Medtronic Energy and Component Center (MECC) site.