PMA P220023S012
- Device
- Paradise™ Ultrasound Renal Denervation System (Paradise System); Paradise™ Catheter
- Applicant
- Recor Medical, Inc.
- PMA number
- P220023
- Supplement
- S012
- Product code
- QYI
- Decision date
- 2026-07-29
- Classification
- Cardiovascular
- Generic name
- Ablation catheter, renal denervation
- Approval order statement
- approval for changes to the manufacturing process of the ultrasound transducer
Current openFDA PMA Record#
- Device
- Paradise™ Ultrasound Renal Denervation System (Paradise System); Paradise™ Catheter
- Applicant
- Recor Medical, Inc.
- PMA number
- P220023
- Supplement
- S012
- Product code
- QYI
- Generic name
- Ablation catheter, renal denervation
- Decision date
- 2026-07-29
- Decision code
- OK30
- Date received
- 2026-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for changes to the manufacturing process of the ultrasound transducer