POLARx FIT Cryoablation Balloon Catheters
FDA premarket approval P220032/S007 · decided 2024-08-23
Approval details
- PMA number
- P220032
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POLARx FIT Cryoablation Balloon Catheters
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-07-26
- Decision date
- 2024-08-23
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- the addition of a visual inspection step to identify an issue related to field reports of high pressure error messages
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