FDA.reportPublic FDA data

PMA P080025S236

Device
InterStim® Therapy System, Verify® Evaluation System
Applicant
Medtronic Neuromodulation
PMA number
P080025
Supplement
S236
Product code
QON
Decision date
2021-08-24
Generic name
Implanted electrical device intended for treatment of fecal incontinence
Approval order statement
Change to sterilization process, addition of the Cardiac Rhythm Management (CRM) sterilization area at the Villalba site for the sterilization of the leads (models 978A1 and 978B1) and extensions (models 3560022 and 3560030).

Current openFDA PMA Record#

Device
InterStim® Therapy System, Verify® Evaluation System
Applicant
Medtronic Neuromodulation
PMA number
P080025
Supplement
S236
Product code
QON
Generic name
Implanted electrical device intended for treatment of fecal incontinence
Decision date
2021-08-24
Decision code
OK30
Date received
2021-08-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to sterilization process, addition of the Cardiac Rhythm Management (CRM) sterilization area at the Villalba site for the sterilization of the leads (models 978A1 and 978B1) and extensions (models 3560022 and 3560030).