PMA P080025S224

Device: InterStim Therapy System and Verify Evaluation System (SNS Bowel)
Applicant: Medtronic Neuromodulation
Product code: QON
Decision date: 2021-08-30
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Approval for a cleaning process change at DSM Biomedical in Berkeley California, a supplier to Medtronic Neuromodulation, that involves the addition of an option to replace solvent cleaning the equipment between material lots with a process that uses the next lot of material to purge the system (the first 30 seconds of material coming out of this portion of the manufacturing line is discarded). The change involves the continuous reactor system to be purged between production batches of same hardness grade and purged and cleaned between production batches of different hardness.

Current openFDA PMA Record#

Device: InterStim Therapy System and Verify Evaluation System (SNS Bowel)
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S224
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2021-08-30
Decision code: APPR
Date received: 2021-01-25
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a cleaning process change at DSM Biomedical in Berkeley California, a supplier to Medtronic Neuromodulation, that involves the addition of an option to replace solvent cleaning the equipment between material lots with a process that uses the next lot of material to purge the system (the first 30 seconds of material coming out of this portion of the manufacturing line is discarded). The change involves the continuous reactor system to be purged between production batches of same hardness grade and purged and cleaned between production batches of different hardness.