PMA P220032S010

Device: Boston Scientific Cardiac Cryoablation System
Applicant: Boston Scientific Corporation
PMA number: P220032
Supplement: S010
Product code: OAE
Decision date: 2025-03-21
Classification: Cardiovascular
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: approval for modifications to the device labeling, including additional warnings and recommendations regarding esophageal protection

Current openFDA PMA Record#

Device: Boston Scientific Cardiac Cryoablation System
Applicant: Boston Scientific Corporation
PMA number: P220032
Supplement: S010
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2025-03-21
Decision code: APPR
Date received: 2025-02-21
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for modifications to the device labeling, including additional warnings and recommendations regarding esophageal protection