Paradise Ultrasound Renal Denervation System; Paradise Catheter
FDA premarket approval P220023/S008 · decided 2025-03-25
Approval details
- PMA number
- P220023
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Paradise Ultrasound Renal Denervation System; Paradise Catheter
- Generic name
- Ablation catheter, renal denervation
- Applicant
- Recor Medical, Inc.
- Date received
- 2025-03-05
- Decision date
- 2025-03-25
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- QYI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Palo Alto, CA
- Statement
- approval for an alternative supplier of a coaxial cable component of the Paradise Catheter System
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