POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories
FDA premarket approval P220032/S001 · decided 2023-11-17
Approval details
- PMA number
- P220032
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- 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
- 2023-09-07
- Decision date
- 2023-11-17
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220032. Based upon the information submitted, the PMA supplement is approved.
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