ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
FDA premarket approval P020018/S009 · decided 2006-06-01
Approval details
- PMA number
- P020018
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2006-05-01
- Decision date
- 2006-06-01
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE ZENITH FLEX AAA ENDOVASCULAR GRAFT ANCILLARY COMPONENT LABELING TO CLARIFY THE LENGTH LIMITATIONS FOR USE OF THE 58 MM LENGTH MAIN BODY EXTENSION WHEN USED IN CONJUNCTION WITH THE SHORTEST ZENITH MAIN BODY COMPONENTS.
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