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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.
 
Trade NameFREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY, MODEL 995MS
Classification Nameheart-valve, non-allograft tissue
ApplicantMEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
PMA NumberP970031
Supplement NumberS010
Date Received05/03/2001
Decision Date10/31/2001
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the freestyle subcoronary bioprosthesis, modified subcoronary configuration, model 995ms, available in sizes 19 mm, 21 mm, 23 mm, 25 mm, and 27 mm. The device is indicated for the replacement of malfunctioning native or prosthetic aortic valves.
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