PMA P200030S004
- Device
- GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)
- Applicant
- W. L. Gore And Associates, Inc.
- PMA number
- P200030
- Supplement
- S004
- Product code
- MIH
- Decision date
- 2021-10-06
- Generic name
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Approval order statement
- Removal Of Tensile Sample Testing For The Constraining Loop Subassembly
Current openFDA PMA Record
- Device
- GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)
- Applicant
- W. L. Gore and Associates, Inc.
- PMA number
- P200030
- Supplement
- S004
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-10-06
- Decision code
- OK30
- Date received
- 2021-09-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of tensile sample testing for the constraining loop subassembly.