ZENITH FLEX AAA ENDOVASCULAR GRAFT
FDA premarket approval P020018/S007 · decided 2006-03-23
Approval details
- PMA number
- P020018
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ZENITH FLEX AAA ENDOVASCULAR GRAFT
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2005-10-17
- Decision date
- 2006-03-23
- Days to decision
- 157 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY SUBMISSION FOR THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT.
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