PMA P970004S448

Device: InterStim™ Therapy System, Verify™ Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S448
Product code: EZW
Decision date: 2026-05-07
Classification: Gastroenterology, Urology
Generic name: Stimulator, electrical, implantable, for incontinence
Approval order statement: approval to implement a new cleaning and passivation equipment at a Medtronic external supplier, Tegra Medical Dartmouth and Tegra Medical Costa Rica

Current openFDA PMA Record#

Device: InterStim™ Therapy System, Verify™ Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S448
Product code: EZW
Generic name: Stimulator, electrical, implantable, for incontinence
Decision date: 2026-05-07
Decision code: OK30
Date received: 2026-04-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to implement a new cleaning and passivation equipment at a Medtronic external supplier, Tegra Medical Dartmouth and Tegra Medical Costa Rica