PMA P970004S362

Device: InterStim Therapy System, Verify Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S362
Product code: EZW
Decision date: 2022-05-12
Generic name: Stimulator, electrical, implantable, for incontinence
Approval order statement: Changes to the final acceptance procedures for hybrid modules and assemblies and the hybrid final pack and bag RFID process specifications procedures to correct identified gaps in standard work as determined during a CAPA investigation.

Current openFDA PMA Record#

Device: InterStim Therapy System, Verify Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S362
Product code: EZW
Generic name: Stimulator, electrical, implantable, for incontinence
Decision date: 2022-05-12
Decision code: OK30
Date received: 2022-05-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the final acceptance procedures for hybrid modules and assemblies and the hybrid final pack and bag RFID process specifications procedures to correct identified gaps in standard work as determined during a CAPA investigation.