PMA P220026S004

Device: Symplicity Spyral Multi-Electrode Renal Denervation Catheter
Applicant: Medtronic, Inc.
PMA number: P220026
Supplement: S004
Product code: QYI
Decision date: 2024-02-29
Classification: Cardiovascular
Generic name: Ablation catheter, renal denervation
Approval order statement: introduction of a Radio Frequency Identification (RFID) tag screening as part of incoming inspection at the cable sub-assembly supplier

Current openFDA PMA Record#

Device: Symplicity Spyral Multi-Electrode Renal Denervation Catheter
Applicant: Medtronic, Inc.
PMA number: P220026
Supplement: S004
Product code: QYI
Generic name: Ablation catheter, renal denervation
Decision date: 2024-02-29
Decision code: OK30
Date received: 2024-02-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introduction of a Radio Frequency Identification (RFID) tag screening as part of incoming inspection at the cable sub-assembly supplier