PMA P220023S002
- Device
- ReCor Paradise® Ultrasound Renal Denervation System
- Applicant
- Recor Medical, Inc.
- PMA number
- P220023
- Supplement
- S002
- Product code
- QYI
- Decision date
- 2024-02-05
- Classification
- Cardiovascular
- Generic name
- Ablation catheter, renal denervation
- Approval order statement
- Approval of the protocol for the US arm of the Global Paradise System Post Approval Study
Current openFDA PMA Record#
- Device
- ReCor Paradise® Ultrasound Renal Denervation System
- Applicant
- Recor Medical, Inc.
- PMA number
- P220023
- Supplement
- S002
- Product code
- QYI
- Generic name
- Ablation catheter, renal denervation
- Decision date
- 2024-02-05
- Decision code
- APPR
- Date received
- 2023-12-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the US arm of the Global Paradise System Post Approval Study