PMA P050006S072

Device: GORE CARDIOFORM Septal Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S072
Product code: MLV
Decision date: 2019-01-02
Classification: Transcatheter Septal Occluder
Generic name: Transcatheter septal occluder
Approval order statement: Implementation of an alternate machine for use in nitinol wire manufacturing for the following devices: GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE TIGRIS Vascular Stent and GORE CARDIOFORM Septal Occluder.

Current openFDA PMA Record#

Device: GORE CARDIOFORM Septal Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S072
Product code: MLV
Generic name: Transcatheter septal occluder
Decision date: 2019-01-02
Decision code: OK30
Date received: 2018-12-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of an alternate machine for use in nitinol wire manufacturing for the following devices: GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE TIGRIS Vascular Stent and GORE CARDIOFORM Septal Occluder.