GORE EXCLUDER AAA ENDOPROSTHESIS
FDA premarket approval P020004/S074 · decided 2012-11-20
Approval details
- PMA number
- P020004
- Supplement
- S074
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GORE EXCLUDER AAA ENDOPROSTHESIS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2012-08-13
- Decision date
- 2012-11-20
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- APPROVAL FOR THE ADDITION OF THE 35 MM TRUNK-IPSILATERAL LEG AND 36 MM AORTIC EXTENDER COMPONENTS TO THE GORE EXCLUDER AAA ENDOPROSTHESIS PRODUCT PORTFOLIO.
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