PMA P050006S114
- Device
- GORE CARDIOFORM Septal Occluder and GORE CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S114
- Product code
- MLV
- Decision date
- 2024-12-13
- Classification
- Cardiovascular
- Generic name
- Transcatheter septal occluder
- Approval order statement
- the use of new ovens at a current supplier to increase manufacturing capacity for the delivery catheter
Current openFDA PMA Record#
- Device
- GORE CARDIOFORM Septal Occluder and GORE CARDIOFORM ASD Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S114
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2024-12-13
- Decision code
- OK30
- Date received
- 2024-11-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the use of new ovens at a current supplier to increase manufacturing capacity for the delivery catheter