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 Lead, Attain Performa 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: S097
• Date Received: 08/25/2016
• Decision Date: 09/20/2016
• Product Code: OJX
• Advisory Committee: Cardiovascular
• Supplement Type: 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  
Updates to pull test sample sizes and control limits.