Cryo Cable
FDA premarket approval P220032/S003 · decided 2024-03-18
Approval details
- PMA number
- P220032
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cryo Cable
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-02-23
- Decision date
- 2024-03-18
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- the addition of an occlusion test for the Cryo-Cable Vacuum Line
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510(k) clearances by this applicant
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| MOSES Raydar™ (K260100) | Boston Scientific Corporation | 2026-05-18 |
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