Valiant Thoracic Stent Graft with the Captivia Delivery System
FDA premarket approval P100040/S072 · decided 2025-05-20
Approval details
- PMA number
- P100040
- Supplement
- S072
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2025-04-21
- Decision date
- 2025-05-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- the use of surrogate fatigue testing to support the fatigue requirements of certain nitinol stent wire lots used in the manufacturing of the Valiant Thoracic Stent Graft
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