FDA.reportPublic FDA data

PMA P970004S452

Device
InterStim TM Therapy System; Verify TM Evaluation System (97800)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S452
Product code
EZW
Decision date
2026-06-05
Classification
Gastroenterology, Urology
Generic name
Stimulator, electrical, implantable, for incontinence
Approval order statement
for expansion of incoming electrolyte salt acceptance limits. Specifically, to expand LiAsF6 electrolyte salt moisture content acceptance limit from: = 100 parts per million (ppm) to: = 200 ppm and expand LiAsF6 electrolyte salt insoluble acceptance limit from: = 20 ppm to: = 200 ppm

Current openFDA PMA Record#

Device
InterStim TM Therapy System; Verify TM Evaluation System (97800)
Applicant
Medtronic Neuromodulation
PMA number
P970004
Supplement
S452
Product code
EZW
Generic name
Stimulator, electrical, implantable, for incontinence
Decision date
2026-06-05
Decision code
OK30
Date received
2026-05-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
for expansion of incoming electrolyte salt acceptance limits. Specifically, to expand LiAsF6 electrolyte salt moisture content acceptance limit from: = 100 parts per million (ppm) to: = 200 ppm and expand LiAsF6 electrolyte salt insoluble acceptance limit from: = 20 ppm to: = 200 ppm