PMA P080025S241

Device: InterStim Therapy System, Verify Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S241
Product code: QON
Decision date: 2021-12-03
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Replacement of current Underfill Dispense System (Asymtek Axiom X-1020) with a new system (Asymtek Spectrum II) at Medtronic Tempe Campus (MTC).

Current openFDA PMA Record#

Device: InterStim Therapy System, Verify Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S241
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2021-12-03
Decision code: OK30
Date received: 2021-11-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of current Underfill Dispense System (Asymtek Axiom X-1020) with a new system (Asymtek Spectrum II) at Medtronic Tempe Campus (MTC).