FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ablation Catheter, Renal Denervation
PMA: P220026
·
Decision Nov 17, 2023
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Ablation Catheter, Renal Denervation
- Trade Name
- Symplicity Spyral Renal Denervation System
- PMA Number
- P220026
- 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
- November 17, 2023
- Date Received
- November 8, 2022
- Expedited Review
- N
- Docket Number
- 23M-5472
Advisory Committee Statement
The Symplicity Spyral Multi-Electrode Renal Denervation Catheter and the Symplicity G3 RF Generator are indicated to reduce blood pressure as an adjunctive treatment in patients with hypertension in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.
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 |