PMA P080025S271

Device: InterStim® Therapy System, Verify® Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S271
Product code: QON
Decision date: 2022-11-22
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Add a larger facility to house the manufacturing operations of JunoPacific and Meier Toll and Engineering, which are both owned by Cretex Companies, within the same facility.

Current openFDA PMA Record#

Device: InterStim® Therapy System, Verify® Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S271
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2022-11-22
Decision code: OK30
Date received: 2022-11-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add a larger facility to house the manufacturing operations of JunoPacific and Meier Toll and Engineering, which are both owned by Cretex Companies, within the same facility.