PMA P060019S057

Device: IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF
Applicant: Irvine Biomedical, Inc.
PMA number: P060019
Supplement: S057
Product code: OAD
Decision date: 2025-05-28
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: the addition of an alternate tubing supplier for the high-pressure tube in the Cool Point Tubing Set

Current openFDA PMA Record#

Device: IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF
Applicant: Irvine Biomedical, Inc.
PMA number: P060019
Supplement: S057
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2025-05-28
Decision code: OK30
Date received: 2025-04-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of an alternate tubing supplier for the high-pressure tube in the Cool Point Tubing Set