Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: TORONTO SPV VALVE
• Generic Name: heart-valve, non-allograft tissue
• Applicant: St. Jude Medical, Inc.; 177 E. County Rd. B E.; St Paul, MN 55117
• PMA Number: P970030
• Supplement Number: S001
• Date Received: 12/22/1997
• Decision Date: 09/30/1998
• Withdrawal Date: 05/14/2012
• Product Code: LWR
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: 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.