Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: RIATA ST OPTIM AND RIATA STS OPTIM LEADS
• Classification Name: permanent defibrillator electrodes
• Generic Name: transvenous defibrillation lead
• Applicant: ST. JUDE MEDICAL, INC.
• PMA Number: P950022
• Supplement Number: S073
• Date Received: 07/13/2010
• Decision Date: 09/09/2010
• Product Code: NVY [ Registered Establishments with NVY ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Approval of the post-approval study protocol.