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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 Nametissue, heart valve
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S006