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: TENDRIL 1888 LEAD
• Classification Name: drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
• Generic Name: cardiovascular permanent pacemaker electrode
• Applicant: ST. JUDE MEDICAL, INC.
• PMA Number: P960013
• Supplement Number: S049
• Date Received: 08/19/2009
• Decision Date: 09/17/2009
• Product Code: NVN [ Registered Establishments with NVN ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Addition of an oven curing step.