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: Patient Cable
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Medtronic Cardiac Rhythm Disease Management; 8200 Coral Sea St. N.E; Mounds View, MN 55112
• PMA Number: P820003
• Supplement Number: S141
• Date Received: 09/28/2023
• Decision Date: 12/15/2023
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Supplement Type: Real-Time Process
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for packaging and sterilization changes for the Disposable Safety Patient Cables Models 5846A, 5846AL, 5846V, and 5846VL.