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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
8299 central ave., n.e.
spring lake park, MN 55432-3576
PMA NumberP790018
Supplement NumberS037
Date Received04/19/2001
Decision Date11/09/2001
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the hall easy-fit prosthetic heart valve, models a7700 (aortic) and m7700 (mitral), available in aortic sizes 19, 21, 23, 25, 27, and 29 mm, and in mitral sizes 23, 25, 27, 29, and 31 mm. The device is indicated for the replacement of malfunctioning native or prosthetic aortic or mitral valves. The hall prosthetic heart valve is a modification of the approved medtronic hal prosthetic heart valve; the modification consisting of a new sewing cuff material and design, intended for supra-annular placement. The supplement additionally requested introduction of the hall e prosthetic heart valve product line into the approved steam sterilization process for the medtronic h prosthetic heart valve.