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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTORONTO SPV VALVE
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart-valve, non-allograft tissue
Applicant
St. Jude Medical, Inc.
177 e.county rd. b east
st paul, MN 55117
PMA NumberP970030
Date Received07/07/1997
Decision Date11/04/1997
Withdrawal Date 05/14/2012
Product Code
LWR[ Registered Establishments with LWR ]
Docket Number 98M-0836
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Toronto SPV(R) Valve, Model SPA-101, sizes 21, 23, 25, 27, and 29 mm and the Toronto SPV(R) Valve Sizer Set, Model 300SPA. The device is a tissue heart valve and is indicated for the replacement of malfunctioning native or prosthetic aortic valves.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S006 
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