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 | SYNCHROMED AND SYNCHROMED II IMPLANTABLE INFUSION PUMPS |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S059 |
Date Received | 02/23/2004 |
Decision Date | 03/17/2004 |
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 |
Approval Order Statement APPROVAL FOR: THE ADDITION OF TIME LABELS AND A DAILY DOSE FILED TO THE PROGRAMMING SCREENS; THE ADDITION OF RECENTLY APPROVED CATHETER MODELS, MODEL 8731 AND MODEL 8749, TO THE DROP-DOWN LIST; CHANGES TO THE SCREEN USED TO ENTER THE DEMO MODE, AND THE RESULTING UPDATES TO THE PROGRAMMING GUIDES. |
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