PMA P220023S007
- Device
- Paradise Ultrasound Renal Denervation System; Paradise™ Catheter
- Applicant
- Recor Medical, Inc.
- PMA number
- P220023
- Supplement
- S007
- Product code
- QYI
- Decision date
- 2025-03-06
- Classification
- Cardiovascular
- Generic name
- Ablation catheter, renal denervation
- Approval order statement
- a change to the supplier of the piezoelectric material block used in manufacturing ultrasound transducers
Current openFDA PMA Record#
- Device
- Paradise Ultrasound Renal Denervation System; Paradise™ Catheter
- Applicant
- Recor Medical, Inc.
- PMA number
- P220023
- Supplement
- S007
- Product code
- QYI
- Generic name
- Ablation catheter, renal denervation
- Decision date
- 2025-03-06
- Decision code
- OK30
- Date received
- 2025-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the supplier of the piezoelectric material block used in manufacturing ultrasound transducers