GORE EXCLUDER BIFURCATED ENDOPROSTHESIS
FDA premarket approval P020004/S004 · decided 2003-10-15
Approval details
- PMA number
- P020004
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GORE EXCLUDER BIFURCATED ENDOPROSTHESIS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2003-05-27
- Decision date
- 2003-10-15
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- APPROVAL FOR THE ADDITION OF LARGER SIZE CONTRALATERAL LEG COMPONENTS FOR THE EXCLUDER BIFURCATED ENDOPROSTHESIS (EBE) AND FOR THE ADDITION OF THE W.L. GORE & ASSOCIATES WOODY SPRINGS FACILITY LOCATED IN FLAGSTAFF, ARIZONA, WHICH WILL BE USED TO MANUFACTURE THE LARGER SIZED CONTRALATERAL LEG COMPONENTS.
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