PMA P150026S013

Device: HeartLight® X3 Catheter with Excalibur Balloon™
Applicant: Cardiofocus, Inc.
PMA number: P150026
Supplement: S013
Product code: OAE
Decision date: 2022-04-02
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: Approval for a manufacturing site located at Sterigenics, Inc., 84 Park Road, Queensbury, NY 12804 as an alternate sterilization site for the HeartLight X3 Catheter with Excalibur Balloon.

Current openFDA PMA Record#

Device: HeartLight® X3 Catheter with Excalibur Balloon™
Applicant: Cardiofocus, Inc.
PMA number: P150026
Supplement: S013
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2022-04-02
Decision code: APPR
Date received: 2022-03-04
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Sterigenics, Inc., 84 Park Road, Queensbury, NY 12804 as an alternate sterilization site for the HeartLight X3 Catheter with Excalibur Balloon.