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: IMPLANTABLE CARDIAC PACEMAKER PULSE GENERATOR
• Generic Name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
• Applicant: St. Jude Medical, Inc.; 15900 Valley View Ct.; Sylmar, CA 91342
• PMA Number: P880006
• Supplement Number: S076
• Date Received: 11/30/2011
• Decision Date: 04/13/2012
• Withdrawal Date: 05/07/2018
• Product Code: NIK
• Advisory Committee: Cardiovascular
• Supplement Type: 135 Review Track For 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR CHANGES TO STERILIZATION LOADING CONFIGURATIONS.