PMA P970004S328

Device: InterStim Therapy System, Verify Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S328
Product code: EZW
Decision date: 2021-04-09
Generic name: Stimulator, electrical, implantable, for incontinence
Approval order statement: Approval for minor design change to the foramen needles provided with various InterStim Therapy lead kits and separately packaged kits.

Current openFDA PMA Record#

Device: InterStim Therapy System, Verify Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S328
Product code: EZW
Generic name: Stimulator, electrical, implantable, for incontinence
Decision date: 2021-04-09
Decision code: APPR
Date received: 2021-01-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for minor design change to the foramen needles provided with various InterStim Therapy lead kits and separately packaged kits.