ZENITH FLEX AAA ENDOVASCULAR GRAFT
FDA premarket approval P020018/S037 · decided 2011-06-07
Approval details
- PMA number
- P020018
- Supplement
- S037
- 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
- 2010-08-30
- Decision date
- 2011-06-07
- Days to decision
- 281 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL TO ADD THE ZENITH SPIRAL-Z AAA ENDOVASCULAR GRAFT ILIAC LEG TO THE EXISTING ZENITH FLEX AAA ENDOVASCULAR GRAFT PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZENITH SPIRAL-Z AAA ENDOVASCULAR GRAFT ILIAC LEG AND IS INDICATED FOR USE WITH THE ZENITH AAA ENDOVASCULAR GRAFT FAMILY OF PRODUCTS, INCLUDING THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, ZENITH RENU ANCILLARY GRAFT, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT, OR ZENITH BRANCH ILIAC ENDOVASCULAR GRAFT, DURIN
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