PMA P050006S014
- Device
- GORE HELEX SEPTAL OCCLUDER
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S014
- Product code
- MLV
- Decision date
- 2011-01-05
- Classification
- Transcatheter Septal Occluder
- Generic name
- Transcatheter septal occluder
- Approval order statement
- APPROVAL FOR UPDATED DEVICE LABELING.
Current openFDA PMA Record#
- Device
- GORE HELEX SEPTAL OCCLUDER
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S014
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2011-01-05
- Decision code
- APPR
- Date received
- 2009-09-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR UPDATED DEVICE LABELING.