PMA P050006S096

Device: GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S096
Product code: MLV
Decision date: 2021-11-29
Generic name: Transcatheter septal occluder
Approval order statement: Addition of an alternate fiber braiding supplier for the retrieval cord fiber used in the delivery system assemblies for the subject device(s).

Current openFDA PMA Record#

Device: GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S096
Product code: MLV
Generic name: Transcatheter septal occluder
Decision date: 2021-11-29
Decision code: OK30
Date received: 2021-11-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate fiber braiding supplier for the retrieval cord fiber used in the delivery system assemblies for the subject device(s).