- Device
- Paradise Ultrasound Renal Denervation System, Paradise Cartridge, Paradise Generator
- Applicant
- Recor Medical, Inc.
- PMA number
- P220023
- Supplement
- S004
- Product code
- QYI
- Generic name
- Ablation catheter, renal denervation
- Decision date
- 2024-12-20
- Decision code
- OK30
- Date received
- 2024-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add torque inspections at the supplier final inspection stage for the Paradise Cartridge and Paradise Generator system components