PMA P080025S269

Device: InterStim® Therapy System, Verify® Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S269
Product code: QON
Decision date: 2022-10-27
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Approval for removal of the applicator sponge from the Interstim Evaluation Lead Kit and updated package labeling for the InterStim Evaluation Lead Kit.

Current openFDA PMA Record#

Device: InterStim® Therapy System, Verify® Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S269
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2022-10-27
Decision code: APPR
Date received: 2022-09-27
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for removal of the applicator sponge from the Interstim Evaluation Lead Kit and updated package labeling for the InterStim Evaluation Lead Kit.