VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
FDA premarket approval P100040/S021 · decided 2015-10-30
Approval details
- PMA number
- P100040
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2015-05-20
- Decision date
- 2015-10-30
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR AN UPDATE TO THE VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM¿S INSTRUCTIONS FOR USE (IFU) TO INCLUDE THE VALOR II POST APPROVAL STUDY DATA.
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