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: CARELINK MONITOR MODELS 2490G, 2490H, 2490J, AND THE 2020A CARDIOSIGHT READER
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: Medtronic Cardiac Rhythm Disease Management; 8200 Coral Sea St. N.E; Mounds View, MN 55112
• PMA Number: P900061
• Supplement Number: S071
• Date Received: 12/01/2006
• Decision Date: 09/14/2007
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS SERVICES CORP., PENANG, MALAYSIA.