MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM
FDA premarket approval P100021/S058 · decided 2017-02-23
Approval details
- PMA number
- P100021
- Supplement
- S058
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2016-10-06
- Decision date
- 2017-02-23
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval to transfer device component of the Talent Occluder to Endurant Stent Graft System.
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