PMA P050006S108

Device: GORE® CARDIOFORM Septal Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S108
Product code: MLV
Decision date: 2023-10-30
Classification: Cardiovascular
Generic name: Transcatheter septal occluder
Approval order statement: changes made to the knot tying method used in the GORE® CARDIOFORM Septal Occluder manufacturing process to bond the Retrieval Cord to the Retrieval Cord Lock

Current openFDA PMA Record#

Device: GORE® CARDIOFORM Septal Occluder
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S108
Product code: MLV
Generic name: Transcatheter septal occluder
Decision date: 2023-10-30
Decision code: OK30
Date received: 2023-10-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes made to the knot tying method used in the GORE® CARDIOFORM Septal Occluder manufacturing process to bond the Retrieval Cord to the Retrieval Cord Lock