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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.
 
DeviceFREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM
Generic Nameheart-valve, non-allograft tissue
ApplicantMedtronic, Inc.
1851 EAST DEERE AVE.
SANTA ANA, CA 92705
PMA NumberP970031
Supplement NumberS013
Date Received07/28/2003
Decision Date12/08/2003
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM. THE SUPPLEMENT REQUESTED APPROVAL OF THIS SIZE AS AN ADDITION TO THE EXISTING, APPROVED (OCTOBER 31, 2001, UNDER SUPPLEMENT S010) PRODUCT LINE OF SIZES 19, 21, 23, 25, AND 27 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
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