PMA P220026S019

Device: Symplicity G3 Renal Denervation RF Generator
Applicant: Medtronic, Inc.
PMA number: P220026
Supplement: S019
Product code: QYI
Decision date: 2026-10-23
Classification: Cardiovascular
Generic name: Ablation catheter, renal denervation
Approval order statement: approval for replacement of manufacturing lines and inspection process changes for circuit boards in the Symplicity G3 Renal Denervation RF Generator

Current openFDA PMA Record#

Device: Symplicity G3 Renal Denervation RF Generator
Applicant: Medtronic, Inc.
PMA number: P220026
Supplement: S019
Product code: QYI
Generic name: Ablation catheter, renal denervation
Decision date: 2026-10-23
Decision code: OK30
Date received: 2026-09-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for replacement of manufacturing lines and inspection process changes for circuit boards in the Symplicity G3 Renal Denervation RF Generator