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: DURATA FAMILY OF HIGH VOLTAGE LEADS
• Classification Name: permanent defibrillator electrodes
• Generic Name: transvenous defibrillation lead
• Applicant: ST. JUDE MEDICAL, INC.
• PMA Number: P950022
• Supplement Number: S076
• Date Received: 01/27/2011
• Decision Date: 02/10/2011
• Product Code: NVY [ Registered Establishments with NVY ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Use of an alternate supplier for a lead component.