PMA P050006S085
- Device
- GORE CARDIOFORM Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S085
- Product code
- MLV
- Decision date
- 2020-10-23
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Approval of the revised protocol, and subsequent revised version of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- GORE CARDIOFORM Septal Occluder
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P050006
- Supplement
- S085
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2020-10-23
- Decision code
- APPR
- Date received
- 2020-07-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol, and subsequent revised version of the protocol for the post-approval study (PAS) protocol.