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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 NameHALL EASY-FIT PROSTHETIC HEART VALVE
Classification Nameheart-valve, mechanical
Generic Nameheart valve
ApplicantMEDTRONIC VASCULAR
PMA NumberP790018
Supplement NumberS042
Date Received12/26/2001
Decision Date01/11/2002
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to include one additional precaution statement to the instructions for use.
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