SMARTFREEZE Cryo-Cable
FDA premarket approval P220032/S009 · decided 2025-02-10
Approval details
- PMA number
- P220032
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SMARTFREEZE Cryo-Cable
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Boston Scientific Corporation
- Date received
- 2025-01-31
- Decision date
- 2025-02-10
- Days to decision
- 10 days
- Decision code
- OK30
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- the addition of new equipment to perform the High-Pressure Leak Test inspection using an equivalent design specification output for the SMARTFREEZE Cryo-Cable
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