Paradise® Ultrasound Renal Denervation System
FDA premarket approval P220023/S003 · decided 2024-10-25
Approval details
- PMA number
- P220023
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Paradise® Ultrasound Renal Denervation System
- Generic name
- Ablation catheter, renal denervation
- Applicant
- Recor Medical, Inc.
- Date received
- 2024-09-26
- Decision date
- 2024-10-25
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QYI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Palo Alto, CA
- Statement
- approval to implement a change to the supplier and material of the Paradise Catheter strain relief component
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