Symplicity Spyral Multi-Electrode Renal Denervation Catheter, Symplicity G3 Renal Devervation RF Generator
FDA premarket approval P220026/S001 · decided 2024-02-15
Approval details
- PMA number
- P220026
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Symplicity Spyral Multi-Electrode Renal Denervation Catheter, Symplicity G3 Renal Devervation RF Generator
- Generic name
- Ablation catheter, renal denervation
- Applicant
- Medtronic, Inc.
- Date received
- 2023-12-18
- Decision date
- 2024-02-15
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- QYI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval of the protocol for the post-approval study Spyral AFFIRM (New-Enrollment Registry Study)
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