PMA P220023S011
- Device
- Paradise™ Ultrasound Renal Denervation System (Paradise System)
- Applicant
- Recor Medical, Inc.
- PMA number
- P220023
- Supplement
- S011
- Product code
- QYI
- Decision date
- 2026-08-13
- Classification
- Cardiovascular
- Generic name
- Ablation catheter, renal denervation
- Approval order statement
- Approval of revision to the protocol for the Post-Approval Study (PAS) referenced above.
Current openFDA PMA Record#
- Device
- Paradise™ Ultrasound Renal Denervation System (Paradise System)
- Applicant
- Recor Medical, Inc.
- PMA number
- P220023
- Supplement
- S011
- Product code
- QYI
- Generic name
- Ablation catheter, renal denervation
- Decision date
- 2026-08-13
- Decision code
- APPR
- Date received
- 2026-05-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of revision to the protocol for the Post-Approval Study (PAS) referenced above.