PMA P020004S062
- Device
- GORE EXCLUDER AAA ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P020004
- Supplement
- S062
- Product code
- MIH
- Decision date
- 2011-11-10
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN PHOENIX, ARIZONA.
Current openFDA PMA Record#
- Device
- GORE EXCLUDER AAA ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P020004
- Supplement
- S062
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2011-11-10
- Decision code
- APPR
- Date received
- 2011-05-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN PHOENIX, ARIZONA.