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: COGNIS CRT-D, LIVIAN CRT-D, CONTAK RENEWAL 3 RF HE CRT-D
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Boston Scientific Corp.; 4100 HAMLINE AVE NORTH; ST. PAUL, MN 55112
• PMA Number: P010012
• Supplement Number: S301
• Date Received: 08/29/2012
• Decision Date: 01/18/2013
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.