ZENITH FLEX ENDOVASCULAR GRAFT
FDA premarket approval P020018/S034 · decided 2010-03-31
Approval details
- PMA number
- P020018
- Supplement
- S034
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ZENITH FLEX ENDOVASCULAR GRAFT
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2010-03-10
- Decision date
- 2010-03-31
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR THE ADDITION OF MANUFACTURING INSTRUCTIONS TO ASSURE THAT THE PROXIMAL TRIGGER WIRE IS NOT INADVERTENTLY ATTACHED TO BOTH TRIGGER KNOBS OF THE DELIVERY SYSTEM.
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