PMA P050006S097

Device: GORE CARDIOFORM Septal Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S097
Product code: MLV
Decision date: 2022-01-27
Generic name: Transcatheter septal occluder
Approval order statement: Changes to the inspection method and equipment used to measure the guidewire port dimensions on the delivery catheter for Gore CARDIOFORM Septal Occluder.

Current openFDA PMA Record#

Device: GORE CARDIOFORM Septal Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S097
Product code: MLV
Generic name: Transcatheter septal occluder
Decision date: 2022-01-27
Decision code: OK30
Date received: 2022-01-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the inspection method and equipment used to measure the guidewire port dimensions on the delivery catheter for Gore CARDIOFORM Septal Occluder.