PMA P970004S435

Device: InterStim® Therapy System, Verify® Evaluation System (SNS Urinary Neurostimulator 97800); (SNS Urinary Neurostimulator I
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S435
Product code: EZW
Decision date: 2025-09-18
Classification: Gastroenterology, Urology
Generic name: Stimulator, electrical, implantable, for incontinence
Approval order statement: approval for updates to the medium rate battery manufacturing process

Current openFDA PMA Record#

Device: InterStim® Therapy System, Verify® Evaluation System (SNS Urinary Neurostimulator 97800); (SNS Urinary Neurostimulator I
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S435
Product code: EZW
Generic name: Stimulator, electrical, implantable, for incontinence
Decision date: 2025-09-18
Decision code: OK30
Date received: 2025-08-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for updates to the medium rate battery manufacturing process