POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories
FDA premarket approval P220032/S002 · decided 2023-12-12
Approval details
- PMA number
- P220032
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-11-13
- Decision date
- 2023-12-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- changes to the sterilization Chamber 9 Programmable Logic Controller at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility
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