PMA P050006S110
- Device
- GORE® CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S110
- Product code
- MLV
- Decision date
- 2024-04-18
- Classification
- Cardiovascular
- Generic name
- Transcatheter septal occluder
- Approval order statement
- a change to the hydrophilic coating process to allow the use of a pre-mixed solution
Current openFDA PMA Record#
- Device
- GORE® CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S110
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2024-04-18
- Decision code
- OK30
- Date received
- 2024-03-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the hydrophilic coating process to allow the use of a pre-mixed solution