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: ISOMED IMPLANTABLE FLOW INFUSION PUMP
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: MEDTRONIC Inc.; 7000 CENTRAL AVENUE NE; MINNEAPOLIS, MN 55432-3576
• PMA Number: P990034
• Supplement Number: S003
• Date Received: 09/04/2002
• Decision Date: 11/08/2002
• Product Code: LKK
• Advisory Committee: General Hospital
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Express GMP Supplement
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR A NEW MANUFACTURING, PACKAGING AND STERILIZATION FACILITY AT MEDTRONIC NEUROLOGICAL AND SPINAL DIVISION, COLUMBIA HEIGHTS, MINNESOTA.