PMA P220026S016

Device
Symplicity Spyral™ Renal Denervation Catheter
Applicant
Medtronic, Inc.
PMA number
P220026
Supplement
S016
Product code
QYI
Decision date
2026-03-25
Classification
Cardiovascular
Generic name
Ablation catheter, renal denervation

Current openFDA PMA Record#

Device
Symplicity Spyral™ Renal Denervation Catheter
Applicant
Medtronic, Inc.
PMA number
P220026
Supplement
S016
Product code
QYI
Generic name
Ablation catheter, renal denervation
Decision date
2026-03-25
Decision code
OK30
Date received
2026-02-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier