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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
Classification Nameheart-valve, mechanical
Generic Nameheart valve
ApplicantMEDTRONIC VASCULAR
PMA NumberP790018
Supplement NumberS032
Date Received01/30/1998
Decision Date07/01/1998
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to manufacture the sewing ring component of the medtronic hall(tm) prosthetic heart valves with knitted polytetrafluoroethylene (ptfe) fabric constructed of ptfe yarn from an alternate supplier. The models affected by the change include model a7700 (sizes 21, 23, 25, 27, 29, and 31 mm) and model m7700 (sizes 23, 25, 27, 29, and 31 mm).
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