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: Attain Ability MRI SureScan Lead, Attain Ability Plus MRI SureScan Lead, Attain Ability Straight MRI SureScan Lead, Atta
• 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: S133
• Date Received: 05/02/2019
• Decision Date: 05/30/2019
• Product Code: OJX
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No