PMA P050006S111

Device: GORE CARDIOFORM Septal Occluder, GORE CARDIOFORM ASD Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S111
Product code: MLV
Decision date: 2025-01-17
Classification: Cardiovascular
Generic name: Transcatheter septal occluder
Approval order statement: Approval for updates to the Instructions for Use to add information related to crossing of a previously implanted occluder.

Current openFDA PMA Record#

Device: GORE CARDIOFORM Septal Occluder, GORE CARDIOFORM ASD Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S111
Product code: MLV
Generic name: Transcatheter septal occluder
Decision date: 2025-01-17
Decision code: APPR
Date received: 2024-05-31
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updates to the Instructions for Use to add information related to crossing of a previously implanted occluder.