PMA P220032S009

Device: SMARTFREEZE™ Cryo-Cable
Applicant: Boston Scientific Corporation
PMA number: P220032
Supplement: S009
Product code: OAE
Decision date: 2025-02-10
Classification: Cardiovascular
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: the addition of new equipment to perform the High-Pressure Leak Test inspection using an equivalent design specification output for the SMARTFREEZE Cryo-Cable

Current openFDA PMA Record#

Device: SMARTFREEZE™ Cryo-Cable
Applicant: Boston Scientific Corporation
PMA number: P220032
Supplement: S009
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2025-02-10
Decision code: OK30
Date received: 2025-01-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of new equipment to perform the High-Pressure Leak Test inspection using an equivalent design specification output for the SMARTFREEZE Cryo-Cable