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 2490G/ 2490H/2490J CARELINK MONITORS FOR USE WITH MODEL 2491 DDMA SOFTWARE
• Generic Name: implantable pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: Medtronic, Inc.; 8200 Coral Sea St. N.E; Mounds View, MN 55112
• PMA Number: P890003
• Supplement Number: S077
• Date Received: 09/20/2004
• Decision Date: 10/19/2004
• Product Code: DXY
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR MODEL 2490G/ 2490H/2490J CARELINK MONITORS FOR USE WITH MODEL 2491 DDMA SOFTWARE.