PMA P050006S098
- Device
- GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S098
- Product code
- MLV
- Decision date
- 2022-02-22
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Removal of cytotoxicity and infrared spectroscopy inspections for incoming components.
Current openFDA PMA Record#
- Device
- GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S098
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2022-02-22
- Decision code
- OK30
- Date received
- 2022-01-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of cytotoxicity and infrared spectroscopy inspections for incoming components.