Symplicity G3 Renal Denervation RF Generator; Symplicity Spyral Multi-Electrode Renal Denervation Catheter
FDA premarket approval P220026/S012 · decided 2025-04-10
Approval details
- PMA number
- P220026
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Symplicity G3 Renal Denervation RF Generator; Symplicity Spyral Multi-Electrode Renal Denervation Catheter
- Generic name
- Ablation catheter, renal denervation
- Applicant
- Medtronic, Inc.
- Date received
- 2025-03-11
- Decision date
- 2025-04-10
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- QYI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval of the revised protocol for the SPYRAL AFFIRM Post-Approval Study.
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510(k) clearances by this applicant
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|---|---|---|
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