PMA P220023S003
- Device
- Paradise® Ultrasound Renal Denervation System
- Applicant
- Recor Medical, Inc.
- PMA number
- P220023
- Supplement
- S003
- Product code
- QYI
- Decision date
- 2024-10-25
- Classification
- Cardiovascular
- Generic name
- Ablation catheter, renal denervation
- Approval order statement
- approval to implement a change to the supplier and material of the Paradise Catheter strain relief component
Current openFDA PMA Record#
- Device
- Paradise® Ultrasound Renal Denervation System
- Applicant
- Recor Medical, Inc.
- PMA number
- P220023
- Supplement
- S003
- Product code
- QYI
- Generic name
- Ablation catheter, renal denervation
- Decision date
- 2024-10-25
- Decision code
- OK30
- Date received
- 2024-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to implement a change to the supplier and material of the Paradise Catheter strain relief component