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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePortico Transcatheter Aortic Valve Implantation System
Generic Nameaortic valve, prosthesis, percutaneously delivered
ApplicantAbbott Medical
177 county road b. east
st. paul, MN 55117
PMA NumberP190023
Date Received09/09/2019
Decision Date09/17/2021
Product Code NPT 
Docket Number 21M-1010
Notice Date 09/10/2021
Advisory Committee Cardiovascular
Clinical TrialsNCT02000115
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Portico Transcatheter Aortic Valve Implantation System. The device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality >= 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 S010 
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