Valiant Navion Thoracic Stent Graft System
FDA premarket approval P100040/S041 · decided 2020-10-05
Approval details
- PMA number
- P100040
- Supplement
- S041
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Valiant Navion Thoracic Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2020-09-04
- Decision date
- 2020-10-05
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for site change for packaging and labeling rework processes.
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