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. |
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Device | TORONTO SPV VALVE |
Generic Name | heart-valve, non-allograft tissue |
Applicant | St. Jude Medical, Inc. 177 E.COUNTY RD. B EAST ST PAUL, MN 55117 |
PMA Number | P970030 |
Date Received | 07/07/1997 |
Decision Date | 11/04/1997 |
Withdrawal Date
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05/14/2012 |
Product Code |
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
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S003 S006 |
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