Paradise® Ultrasound Renal Denervation System
FDA premarket approval P220023 · decided 2023-11-07
Approval details
- PMA number
- P220023
- Trade name
- Paradise® Ultrasound Renal Denervation System
- Generic name
- Ablation catheter, renal denervation
- Applicant
- Recor Medical, Inc.
- Date received
- 2022-10-25
- Decision date
- 2023-11-07
- Days to decision
- 378 days
- Decision code
- APPR
- Product code
- QYI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Palo Alto, CA
- Statement
- The Paradise Ultrasound Renal Denervation System is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.
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