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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHANCOCK MODIFIED ORIFICE II AORTIC BIOPROSTHESIS
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart-valve, non-allograft tissue
Applicant
MEDTRONIC HEART VALVES
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.
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