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: EPIC HF/ATLAS+HF CRT-D FAMILY OF DEVICES
• Classification Name: defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
• Generic Name: defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
• Applicant: St. Jude Medical; 15900 valley view ct.; sylmar, CA 91342-3577
• PMA Number: P030054
• Supplement Number: S069
• Date Received: 09/20/2007
• Decision Date: 10/19/2007
• Product Code: NIK [ Registered Establishments with NIK ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
MINOR CHANGES TO THE AUTOMATED TEST SOFTWARE.