EXCLUDER BIFURCATED ENDOPROSTHESIS
FDA premarket approval P020004/S011 · decided 2005-09-28
Approval details
- PMA number
- P020004
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXCLUDER BIFURCATED ENDOPROSTHESIS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2005-05-06
- Decision date
- 2005-09-28
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- APPROVAL FOR THE ADDITION OF A SHORTER (12 CM) TRUNK/IPSILATERAL COMPONENT TO THE GORE EXCLUDER? BIFURCATED ENDOPROSTHESIS PRODUCT LINE.
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