ZENITH FLEX AAA ENDOVASCULAR GRAFT
FDA premarket approval P020018/S026 · decided 2008-07-09
Approval details
- PMA number
- P020018
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ZENITH FLEX AAA ENDOVASCULAR GRAFT
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2008-03-03
- Decision date
- 2008-07-09
- Days to decision
- 128 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR USE OF THE NEW Z-TRAK INTRODUCTION SYSTEM WITH THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, TO MODIFY THE ILIAC LEG COMPONENT OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, AND TO CHANGE THE PACKAGING FOR THE MAIN BODY AND ILIAC LEG GRAFTS.
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