PMA P200030
- Device
- GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)
- Applicant
- W. L. Gore And Associates, Inc.32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP200030 Supplement NumberS010 Date Received09/06/2022 Decision Date10/05/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- PMA number
- P200030
- Supplement
- S010
- Product code
- MIH
- Decision date
- 2022-10-05
- Generic name
- System, Endovascular Graft, Aortic Aneurysm Treatment
Current openFDA PMA Record
- Device
- GORE® EXCLUDER® Conformable AAA Endoprosthesis
- Applicant
- W. L. Gore and Associates, Inc.
- PMA number
- P200030
- Supplement
- S024
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2026-05-14
- Decision code
- APPR
- Date received
- 2026-02-13
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to remove a warning from the device labeling regarding lack of safety and effectiveness data on the use of your device in treatment of ruptured aneurysms, as well as a brief summary of the supportive data with regard to treatment of ruptured aneurysms.