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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 NumberP790007
Supplement NumberS013
Date Received05/13/1996
Decision Date12/10/1996
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two add'l styles (type f and type g) of the model 250 valve. The device, as modified, will be marketed under the trade names hancock(r) modified orifice ii aortic bioprosthesis, model 250, extended supra-annular flange (type f) and hancock(r) modified orifice ii aortic bioprosthesis, model 250, supra-annular flange (type g). The indication for use and available sizes (19, 21, 23, and 25 mm) for the mdoel 250 valves have not changed.