FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Ablation Catheter, Renal Denervation
PMA: P220023
·
Supplement: S004
·
Decision Dec 20, 2024
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Ablation Catheter, Renal Denervation
- Trade Name
- Paradise Ultrasound Renal Denervation System, Paradise Cartridge, Paradise Generator
- PMA Number
- P220023
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- QYI
- Generic Name
- Ablation catheter, renal denervation
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 20, 2024
- Date Received
- November 26, 2024
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to add torque inspections at the supplier final inspection stage for the Paradise Cartridge and Paradise Generator system components
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 |