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: MODEL 5441 EPG PLASTIC COVER
• 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: S088
• Date Received: 01/12/2009
• Decision Date: 02/11/2009
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
TRANSFERRING OF THE FINAL IN-PROCESS INSPECTION AND FINAL PACKAGE PROCESS STEPS FROM MEDTRONIC RICE CREEK FACILITY TO THE CONTRACT MANUFACTURER.