PMA P970004S371

Device: InterStim® Therapy System, Verify® Evaluation System (SNS Urinary)
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S371
Product code: EZW
Decision date: 2022-07-28
Generic name: Stimulator, electrical, implantable, for incontinence
Approval order statement: Change to the Ionograph Out-of-Control Action Plan (OCAP) and the test sampling plan within the Final Clean process for hybrids manufactured at Medtronic Tempe Campus (MTC).

Current openFDA PMA Record#

Device: InterStim® Therapy System, Verify® Evaluation System (SNS Urinary)
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S371
Product code: EZW
Generic name: Stimulator, electrical, implantable, for incontinence
Decision date: 2022-07-28
Decision code: OK30
Date received: 2022-07-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the Ionograph Out-of-Control Action Plan (OCAP) and the test sampling plan within the Final Clean process for hybrids manufactured at Medtronic Tempe Campus (MTC).