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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 NameTORONTO SPV VALVE
Classification Nameheart-valve, non-allograft tissue
Generic Nametissue, heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP970030
Supplement NumberS001
Date Received12/22/1997
Decision Date09/30/1998
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the proposed post-approval study protocols submitted in response to fda's conditions of approval, items 1 and 2.
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