PMA P080025S272

Device: InterStim® Therapy System, Verify® Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S272
Product code: QON
Decision date: 2022-11-22
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Separation of a manufacturing process, Bond Pad Array (EPA) Lid Removal, as a standalone process for better tracking at internal supplier Medtronic Tempe Campus (MTC); and the addition of a videoscope manufacturing equipment for improved process controls.

Current openFDA PMA Record#

Device: InterStim® Therapy System, Verify® Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S272
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2022-11-22
Decision code: OK30
Date received: 2022-11-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Separation of a manufacturing process, Bond Pad Array (EPA) Lid Removal, as a standalone process for better tracking at internal supplier Medtronic Tempe Campus (MTC); and the addition of a videoscope manufacturing equipment for improved process controls.