PMA P050006S082
- Device
- GORE CARDIOFORM Occluder product family
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S082
- Product code
- MLV
- Decision date
- 2020-04-10
- Generic name
- Transcatheter septal occluder
- Approval order statement
- New ethylene oxide sterilization cycle at Sterigenics in Los Angeles, California.
Current openFDA PMA Record#
- Device
- GORE CARDIOFORM Occluder product family
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S082
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2020-04-10
- Decision code
- OK30
- Date received
- 2020-03-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New ethylene oxide sterilization cycle at Sterigenics in Los Angeles, California.