PMA P050006S027
- Device
- GORE HELEX SEPTAL OCCLUDER
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S027
- Product code
- MLV
- Decision date
- 2012-05-30
- Classification
- Transcatheter Septal Occluder
- Generic name
- Transcatheter septal occluder
- Approval order statement
- CHANGE TO THE AUTOMATED MANUFACTURING AND TESTING DOCUMENTATION PROCESS.
Current openFDA PMA Record#
- Device
- GORE HELEX SEPTAL OCCLUDER
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S027
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2012-05-30
- Decision code
- OK30
- Date received
- 2012-05-01
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO THE AUTOMATED MANUFACTURING AND TESTING DOCUMENTATION PROCESS.