PMA P050006S055
- Device
- GORE CARDIOFORM SEPTAL OCCLUDER SHARED HLC IN-LINE DIPPER
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S055
- Product code
- MLV
- Decision date
- 2016-12-15
- Classification
- Transcatheter Septal Occluder
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Change to colorant formulations to which the GORE CARDIOFORM Septal Occluder Delivery Catheter is exposed.
Current openFDA PMA Record#
- Device
- GORE CARDIOFORM SEPTAL OCCLUDER SHARED HLC IN-LINE DIPPER
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S055
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2016-12-15
- Decision code
- OK30
- Date received
- 2016-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to colorant formulations to which the GORE CARDIOFORM Septal Occluder Delivery Catheter is exposed.