PMA P050006S059

Device: GORE CARDIOFORM Septal Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S059
Product code: MLV
Decision date: 2017-06-16
Classification: Transcatheter Septal Occluder
Generic name: Transcatheter septal occluder
Approval order statement: Updates to bioburden action/alert limits for the Gore Cardioform Septal Occluder, Gore TAG Thoracic Endoprosthesis, and Gore Excluder AAA Endoprosthesis; and reassess alert limits periodically according to the given protocol and report updated alert limits in future PMA annual reports.

Current openFDA PMA Record#

Device: GORE CARDIOFORM Septal Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S059
Product code: MLV
Generic name: Transcatheter septal occluder
Decision date: 2017-06-16
Decision code: OK30
Date received: 2017-05-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Updates to bioburden action/alert limits for the Gore Cardioform Septal Occluder, Gore TAG Thoracic Endoprosthesis, and Gore Excluder AAA Endoprosthesis; and reassess alert limits periodically according to the given protocol and report updated alert limits in future PMA annual reports.