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 MODEL 2490C CARELINK MONITORS
• Generic Name: Pulse generator, permanent, implantable
• Applicant: Medtronic, Inc.; 8200 Coral Sea St. N.E; Mounds View, MN 55112
• PMA Number: P890003
• Supplement Number: S174
• Date Received: 09/08/2009
• Decision Date: 10/08/2009
• Product Code: NVZ
• 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  
CHANGES TO TWO TESTS IN THE FINAL PRODUCT TEST SYSTEM.