FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ablation Catheter, Renal Denervation
PMA: P220026
·
Supplement: S001
·
Decision Feb 15, 2024
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Ablation Catheter, Renal Denervation
- Trade Name
- Symplicity Spyral Multi-Electrode Renal Denervation Catheter, Symplicity G3 Renal Devervation RF Generator
- PMA Number
- P220026
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- QYI
- Generic Name
- Ablation catheter, renal denervation
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 15, 2024
- Date Received
- December 18, 2023
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval of the protocol for the post-approval study Spyral AFFIRM (New-Enrollment Registry Study)
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QYI | Ablation Catheter, Renal Denervation | FDA class 3 | Unknown |