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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 NameMEDTRONIC(R) HALL PROSTHETIC HEART VALVE AND VALVED CONDUITS
Classification Nameheart-valve, mechanical
Generic Nameheart valve & valved conduits
ApplicantMEDTRONIC VASCULAR
PMA NumberP790018
Supplement NumberS024
Date Received01/18/1995
Decision Date05/13/1996
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of occluders made by medtronic carbon implants (mci) of austin, texas, as a component of the medtronic hall prosthetic heart valve and valved conuits, models a7700, m7700, c7700, and z7700.
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