PMA P970004S447

Device
InterStim™ Therapy System, Verify™ Evaluation System (SNS Urinary Implantable Neurostimulators 97800, 97810)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S447
Product code
EZW
Decision date
2026-04-03
Classification
Gastroenterology, Urology
Generic name
Stimulator, electrical, implantable, for incontinence

Current openFDA PMA Record#

Device
InterStim™ Therapy System, Verify™ Evaluation System (SNS Urinary Implantable Neurostimulators 97800, 97810)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S447
Product code
EZW
Generic name
Stimulator, electrical, implantable, for incontinence
Decision date
2026-04-03
Decision code
OK30
Date received
2026-03-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier