PMA P970004S378

Device: InterStim® Therapy System, Verify® Evaluation System (SNS Urinary)
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S378
Product code: EZW
Decision date: 2022-12-08
Generic name: Stimulator, electrical, implantable, for incontinence
Approval order statement: Implementation of a validated test method for the incoming inspection of a component used at the Medtronic Energy and Component Center (MECC).

Current openFDA PMA Record#

Device: InterStim® Therapy System, Verify® Evaluation System (SNS Urinary)
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S378
Product code: EZW
Generic name: Stimulator, electrical, implantable, for incontinence
Decision date: 2022-12-08
Decision code: OK30
Date received: 2022-11-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a validated test method for the incoming inspection of a component used at the Medtronic Energy and Component Center (MECC).