PMA P220026
- Device
- Symplicity Spyral™ Renal Denervation System
- Applicant
- Medtronic, Inc.
- Product code
- QYI
- Decision date
- 2026-07-16
- Generic name
- Ablation catheter, renal denervation
- Approval order statement
- approval for the Symplicity G3 Generator to use updated software version v2.04.00.
Current openFDA PMA Record#
- Device
- Symplicity Spyral™ Renal Denervation System
- Applicant
- Medtronic, Inc.
- PMA number
- P220026
- Supplement
- S017
- Product code
- QYI
- Generic name
- Ablation catheter, renal denervation
- Decision date
- 2026-07-16
- Decision code
- APPR
- Date received
- 2026-04-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the Symplicity G3 Generator to use updated software version v2.04.00.