PMA P050006S118
- Device
- GORE® CARDIOFORM Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S118
- Product code
- MLV
- Decision date
- 2026-05-08
- Classification
- Cardiovascular
- Generic name
- Transcatheter septal occluder
- Approval order statement
- to add an additional bake step to the delivery system component manufacturing process
Current openFDA PMA Record#
- Device
- GORE® CARDIOFORM Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S118
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2026-05-08
- Decision code
- OK30
- Date received
- 2026-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add an additional bake step to the delivery system component manufacturing process