ReCor Paradise® Ultrasound Renal Denervation System
FDA premarket approval P220023/S002 · decided 2024-02-05
Approval details
- PMA number
- P220023
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ReCor Paradise® Ultrasound Renal Denervation System
- Generic name
- Ablation catheter, renal denervation
- Applicant
- Recor Medical, Inc.
- Date received
- 2023-12-08
- Decision date
- 2024-02-05
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- QYI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Palo Alto, CA
- Statement
- Approval of the protocol for the US arm of the Global Paradise System Post Approval Study
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