PMA P050006S012
- Device
- GORE HELEX SEPTAL OCCLUDER
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S012
- Product code
- MLV
- Decision date
- 2009-07-27
- Classification
- Transcatheter Septal Occluder
- Generic name
- Transcatheter septal occluder
- Approval order statement
- APPROVAL FOR A DUPLICATE MANUFACTURING SITE FOR THE FINAL ASSEMBLY STEP OF THE DEVICE.
Current openFDA PMA Record#
- Device
- GORE HELEX SEPTAL OCCLUDER
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S012
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2009-07-27
- Decision code
- APPR
- Date received
- 2009-06-11
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A DUPLICATE MANUFACTURING SITE FOR THE FINAL ASSEMBLY STEP OF THE DEVICE.