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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceMEDTRONIC COREVALVE SYSTEM
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Nameaortic valve, prosthesis, percutaneously delivered
Applicant
MEDTRONIC COREVALVE LLC
3576 unocal place
santa rosa, CA 95403
PMA NumberP130021
Date Received07/22/2013
Decision Date01/17/2014
Product Code
NPT[ Registered Establishments with NPT ]
Docket Number 14M-0166
Notice Date 02/04/2014
Advisory Committee Cardiovascular
Clinical Trials NCT01240902
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the medtronic corevalve™ system. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ? 0. 8 cm2, a mean aortic valve gradient of > 40 mmhg, or a peak aortic-jet velocity of > 4. 0 m/s) and with native aortic annulus diameters between 18 and 29 mm who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy (predicted risk of operative mortality and/or serious irreversible morbidity ? 50% at 30 days).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 
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