ZENITH FLEX AAA ENDOVASCULAR GRAFT
FDA premarket approval P020018/S031 · decided 2009-02-24
Approval details
- PMA number
- P020018
- Supplement
- S031
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ZENITH FLEX AAA ENDOVASCULAR GRAFT
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2009-02-02
- Decision date
- 2009-02-24
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR MODIFYING THE PRODUCT LABELING TO CLARIFY REMOVAL OF THE TRIGGER WIRE.
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