FDA.reportPublic FDA data

PMA P080025S244

Device
InterStim Therapy System, Verify Evaluation System
Applicant
Medtronic Neuromodulation
PMA number
P080025
Supplement
S244
Product code
QON
Decision date
2021-12-08
Generic name
Implanted electrical device intended for treatment of fecal incontinence
Approval order statement
Approval for revisions to physician and patient labeling to align with updated risk management process. The labeling changes include existing precautions elevated to warnings for packaging, single use and effects on other implanted devices.

Current openFDA PMA Record#

Device
InterStim Therapy System, Verify Evaluation System
Applicant
Medtronic Neuromodulation
PMA number
P080025
Supplement
S244
Product code
QON
Generic name
Implanted electrical device intended for treatment of fecal incontinence
Decision date
2021-12-08
Decision code
APPR
Date received
2021-11-16
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for revisions to physician and patient labeling to align with updated risk management process. The labeling changes include existing precautions elevated to warnings for packaging, single use and effects on other implanted devices.