PMA P050006S113

Device: GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S113
Product code: MLV
Decision date: 2024-10-17
Classification: Cardiovascular
Generic name: Transcatheter septal occluder
Approval order statement: the use of new manufacturing equipment to be used by the supplier of the delivery catheter assemblies for the GORE® CARDIOFORM Septal Occluder (GSO Device) and 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: S113
Product code: MLV
Generic name: Transcatheter septal occluder
Decision date: 2024-10-17
Decision code: OK30
Date received: 2024-09-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the use of new manufacturing equipment to be used by the supplier of the delivery catheter assemblies for the GORE® CARDIOFORM Septal Occluder (GSO Device) and GORE® CARDIOFORM ASD Occluder (GCA Device)