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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart-valve, non-allograft tissue
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