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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 NameST. JUDE MEDICAL MECHANICAL HEART VALVE
Classification Nameheart-valve, mechanical
Generic Namecoated aortic valved graft
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS054
Date Received09/27/2000
Decision Date10/23/2000
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the aortic polyester cuff configuration of the sjm(r) master series hp valve. The device, as modified, will be marketed under the trade name sjm(r) master series hemodynamic plus (hp) with flex cuff(tm), model afhpj-505, available in aortic sizes 17, 19, 21, 23, 25, and 27 mm.
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