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 KAPPA 400 SERIES PACEMAKERS
• Generic Name: implantable pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: MEDTRONIC Inc.; 8200 Coral Sea Street NE; Mounds View, MN 55112
• PMA Number: P970012
• Supplement Number: S016
• Date Received: 08/27/2004
• Decision Date: 09/22/2004
• Product Code: DXY
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
CHANGE IN THE STERILIZATION PROCESS.