PMA P220026S014
- Device
- Symplicity Spyral™ Renal Denervation System
- Applicant
- Medtronic, Inc.
- PMA number
- P220026
- Supplement
- S014
- Product code
- QYI
- Decision date
- 2026-09-10
- Classification
- Cardiovascular
- Generic name
- Ablation catheter, renal denervation
- Approval order statement
- inclusion of data from post-approval studies in labeling
Current openFDA PMA Record#
- Device
- Symplicity Spyral™ Renal Denervation System
- Applicant
- Medtronic, Inc.
- PMA number
- P220026
- Supplement
- S014
- Product code
- QYI
- Generic name
- Ablation catheter, renal denervation
- Decision date
- 2026-09-10
- Decision code
- APPR
- Date received
- 2026-01-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- inclusion of data from post-approval studies in labeling