PMA P050006S047
- Device
- GORE HELEX SEPTAL OCCLUDER, GORE CARDIOFORM SEPTAL OCCLUDER
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S047
- Product code
- MLV
- Decision date
- 2015-06-11
- Classification
- Transcatheter Septal Occluder
- Generic name
- Transcatheter septal occluder
- Approval order statement
- IMPLEMENT A CHANGE IN THE TEST METHOD USED FOR RECEIVING ACCEPTANCE ACTIVITIES FOR RAW MATERIALS.
Current openFDA PMA Record#
- Device
- GORE HELEX SEPTAL OCCLUDER, GORE CARDIOFORM SEPTAL OCCLUDER
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S047
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2015-06-11
- Decision code
- OK30
- Date received
- 2015-05-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENT A CHANGE IN THE TEST METHOD USED FOR RECEIVING ACCEPTANCE ACTIVITIES FOR RAW MATERIALS.