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: EPIC HF/ATLAS + HF FAMILY OF CRT-DS
• Classification Name: defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
• Applicant: ST. JUDE MEDICAL
• PMA Number: P030054
• Supplement Number: S194
• Date Received: 07/15/2011
• Decision Date: 08/12/2011
• 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 automated manufacturing tests (ate) used at the half-can level.