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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, non-allograft tissue
Generic Nameheart-valve, non-allograft tissue
1851 east deere ave.
santa ana, CA 92705
PMA NumberP970031
Supplement NumberS011
Date Received06/01/2001
Decision Date11/16/2001
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the freestyle aortic root bioprosthesis, model 995, size 29 mm; implantation techniques, subcoronary, full-root, and root inclusion. The supplement requested approval of this size as an addition to the existing, approved product line of sizes 19, 21, 23, 25, and 27 mm. The device is indicated for the replacement of malfunctioning native or prosthestic aortic valves with the option of aortic root replacement.