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: KAPPA 400 IMPLANTABLE PULSE GENERATOR
• 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: S011
• Date Received: 09/24/2001
• Decision Date: 10/24/2001
• 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

Approval Order Statement  
CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT.