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. |
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Device | ISOMED IMPLANTABLE INFUSION PUMP |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P990034 |
Supplement Number | S002 |
Date Received | 02/25/2002 |
Decision Date | 03/11/2002 |
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: 1) PROPELLANT CHANGE FROM CFC-114 TO N-BUTANE; 2) CAPILLARY TUBING ADJUSTMENT AS A RESULT OF CHANGE TO N-BUTANE; AND 3) UPDATES TO THE TECHNICAL MANUAL. |
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