PMA P080025S257

Device: InterStim Therapy System, Verify Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S257
Product code: QON
Decision date: 2022-05-12
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Changes to the final acceptance procedures for hybrid modules and assemblies and the hybrid final pack and bag RFID process specifications procedures to correct identified gaps in standard work as determined during a CAPA investigation.

Current openFDA PMA Record#

Device: InterStim Therapy System, Verify Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S257
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2022-05-12
Decision code: OK30
Date received: 2022-05-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the final acceptance procedures for hybrid modules and assemblies and the hybrid final pack and bag RFID process specifications procedures to correct identified gaps in standard work as determined during a CAPA investigation.