PMA P050006S116

Device: GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S116
Product code: MLV
Decision date: 2025-12-19
Classification: Cardiovascular
Generic name: Transcatheter septal occluder
Approval order statement: adding an alternative sub-tier supplier for the marker band component of the delivery catheter assemblies for the GORE CARDIOFORM Septal Occluder (GSO Device) and the GORE CARDIOFORM ASD Occluder (GCA Device)

Current openFDA PMA Record#

Device: GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S116
Product code: MLV
Generic name: Transcatheter septal occluder
Decision date: 2025-12-19
Decision code: OK30
Date received: 2025-12-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: adding an alternative sub-tier supplier for the marker band component of the delivery catheter assemblies for the GORE CARDIOFORM Septal Occluder (GSO Device) and the GORE CARDIOFORM ASD Occluder (GCA Device)