POLARx Short Tip (ST) Cryoablation Balloon Catheter, POLARx Long Tip (LT) Cryoablation Balloon Catheter, POLARx FIT S
FDA premarket approval P220032/S005 · decided 2024-07-30
Approval details
- PMA number
- P220032
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POLARx Short Tip (ST) Cryoablation Balloon Catheter, POLARx Long Tip (LT) Cryoablation Balloon Catheter, POLARx FIT S
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-05-07
- Decision date
- 2024-07-30
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- firmware updates to address issues with catheter recognition after connection to the SMARTFREEZE Console
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