ZENITH AAA ENDOVASCULAR GRAFT
FDA premarket approval P020018/S042 · decided 2012-04-13
Approval details
- PMA number
- P020018
- Supplement
- S042
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ZENITH AAA ENDOVASCULAR GRAFT
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2012-01-10
- Decision date
- 2012-04-13
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) LABELING. THE LABELING CHANGES INVOLVED RECOMMENDATIONS TO USERS REGARDING MAINTAINING HEMOSTASIS, USE OF FLUOROSCOPY AND TRIGGER WIRE RELEASE, AND AN ALTERNATIVE SUPRARENAL DEPLOYMENT SEQUENCE.
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