|
Device | ISOMED CONSTANT 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 | S001 |
Date Received | 10/30/2000 |
Decision Date | 11/20/2000 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE MODEL 8472 PUMP: 1) MODIFICATION OF THE MOUNTING OF THE BELLOWS INFUSATE RESERVOIR; 2) SLIGHT CHANGES IN THE CONFIGURATION OF FIVE COMPONENT PARTS IN ORDER TO MAINTAIN THE HEIGHTS OF THE PUMPS FOLLOWING THE CHANGE IN MOUNTING; AND 3) REQUIRED CHANGES IN FIVE WELDS TO FACILITATE THE PREVIOUSLY STATED MODIFICATIONS. |