ZENITH FLEX AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM
FDA premarket approval P020018/S003 · decided 2004-04-15
Approval details
- PMA number
- P020018
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ZENITH FLEX AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2003-12-22
- Decision date
- 2004-04-15
- Days to decision
- 115 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL TO INCREASE THE STENT SPACING (FROM 0-3 MM TO 5 += 1MM) ON THE MAIN BODY AND THE MAIN BODY EXTENSION COMPONENTS OF THE ZENITH AAA ENDOVASCULAR GRAFT.
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