PMA P080025S233

Device: InterStim Therapy System, Verify Evaluation System
Applicant: Medtronic Neuromodulation
Product code: QON
Decision date: 2021-09-01
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Equipment updates in the CEA 2-3 Silicone Molding area (e.g., six additional ovens), updated option for use of temperature recorder (Vaisala Monitoring System Model VL-1700-54T), updated oven mode for the new ovens to use Manual Mode, removal of monitor lot for all ovens, removal of setup lot of new ovens, addition of a new and smaller basket for oven use, and addition of a new toolmaker scope (Nikon MM-40); 2) an update to the applicable work instructions (WI); and 3) the oven operation of allowing the new ovens to be opened during the middle of a run to add or remove lots from the oven and FACTORYworks (FW) updates to support the changes.

Current openFDA PMA Record#

Device: InterStim Therapy System, Verify Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S233
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2021-09-01
Decision code: OK30
Date received: 2021-08-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Equipment updates in the CEA 2-3 Silicone Molding area (e.g., six additional ovens), updated option for use of temperature recorder (Vaisala Monitoring System Model VL-1700-54T), updated oven mode for the new ovens to use Manual Mode, removal of monitor lot for all ovens, removal of setup lot of new ovens, addition of a new and smaller basket for oven use, and addition of a new toolmaker scope (Nikon MM-40); 2) an update to the applicable work instructions (WI); and 3) the oven operation of allowing the new ovens to be opened during the middle of a run to add or remove lots from the oven and FACTORYworks (FW) updates to support the changes.