Valiant Thoratic Stent Graft with Captivia Delivery System
FDA premarket approval P100040/S064 · decided 2024-11-18
Approval details
- PMA number
- P100040
- Supplement
- S064
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Valiant Thoratic Stent Graft with Captivia Delivery System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2024-07-03
- Decision date
- 2024-11-18
- Days to decision
- 138 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- approval for revisions to the instructions for use to add the results of the Collaborative TEVAR Surveillance Project
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