PMA P050006S065
- Device
- Gore Helex Septal Occluder, Gore CardioForm Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S065
- Product code
- MLV
- Decision date
- 2018-05-24
- Classification
- Transcatheter Septal Occluder
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Alternate test lab for impurities testing.
Current openFDA PMA Record#
- Device
- Gore Helex Septal Occluder, Gore CardioForm Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S065
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2018-05-24
- Decision code
- OK30
- Date received
- 2018-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate test lab for impurities testing.