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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 CONFIGURATION, MODEL 995MS, SIZE 29 MM
Classification Nameheart-valve, non-allograft tissue
Generic Nameaortic root modified subcoronary bioprosthesis
ApplicantMEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
PMA NumberP970031
Supplement NumberS013
Date Received07/31/2003
Decision Date12/08/2003
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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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