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: MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD
• Generic Name: Drug eluting permanent left ventricular (lv) pacemaker electrode
• Applicant: Medtronic, Inc.; 710 Medtronic Pkwy. NE; Minneapolis, MN 55432
• PMA Number: P080006
• Supplement Number: S089
• Date Received: 03/01/2016
• Decision Date: 08/24/2016
• Product Code: OJX
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the expansion of MRI conditional labeling for the Amplia MRI and Compia MRI Systems to include 3T MRI.