PMA P970004S341

Device: InterStim® Therapy System, Verify® Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S341
Product code: EZW
Decision date: 2021-08-24
Generic name: Stimulator, electrical, implantable, for 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: P970004
Supplement: S341
Product code: EZW
Generic name: Stimulator, electrical, implantable, for 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).