PMA P220026S012
- Device
- Symplicity G3 Renal Denervation RF Generator; Symplicity Spyral Multi-Electrode Renal Denervation Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P220026
- Supplement
- S012
- Product code
- QYI
- Decision date
- 2025-04-10
- Classification
- Cardiovascular
- Generic name
- Ablation catheter, renal denervation
- Approval order statement
- Approval of the revised protocol for the SPYRAL AFFIRM Post-Approval Study.
Current openFDA PMA Record#
- Device
- Symplicity G3 Renal Denervation RF Generator; Symplicity Spyral Multi-Electrode Renal Denervation Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P220026
- Supplement
- S012
- Product code
- QYI
- Generic name
- Ablation catheter, renal denervation
- Decision date
- 2025-04-10
- Decision code
- APPR
- Date received
- 2025-03-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the SPYRAL AFFIRM Post-Approval Study.