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: QUICKSITE/QUICKFLEX FAMILIES OF LEADS
• Classification Name: defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
• Applicant: ST. JUDE MEDICAL
• PMA Number: P030054
• Supplement Number: S132
• Date Received: 08/28/2009
• Decision Date: 09/25/2009
• Product Code: NIK [ Registered Establishments with NIK ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change in temperature and humidity cure operation.