PMA P220026S005

Device
Symplicity G3™ Renal RF Generator
Applicant
Medtronic, Inc.
PMA number
P220026
Supplement
S005
Product code
QYI
Decision date
2024-07-16
Classification
Cardiovascular
Generic name
Ablation catheter, renal denervation
Approval order statement
changes to, and relocation of, service and repair activities for the Symplicity G3 Generator

Current openFDA PMA Record#

Device
Symplicity G3™ Renal RF Generator
Applicant
Medtronic, Inc.
PMA number
P220026
Supplement
S005
Product code
QYI
Generic name
Ablation catheter, renal denervation
Decision date
2024-07-16
Decision code
APPR
Date received
2024-02-12
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
changes to, and relocation of, service and repair activities for the Symplicity G3 Generator