PMA P050006S095
- Device
- GORE® CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S095
- Product code
- MLV
- Decision date
- 2021-11-16
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Use of the Vision Inspection Part Assembly and Recognition (VIPAR) Station during manufacturing of the GORE CARDIOFORM ASD Occluder.
Current openFDA PMA Record#
- Device
- GORE® CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S095
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2021-11-16
- Decision code
- OK30
- Date received
- 2021-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of the Vision Inspection Part Assembly and Recognition (VIPAR) Station during manufacturing of the GORE CARDIOFORM ASD Occluder.