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 IMPLANTABLE INFUSION SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S061 |
Date Received | 05/19/2004 |
Decision Date | 06/04/2004 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE MEDTRONIC MODEL 8840 N'VISION PROGRAMMER TECHNICAL MANUAL TO ADD A PRECAUTION TO IDENTIFY AN ENVIRONMENT IN WHICH THE DEVICE IS NOT CERTIFIED FOR USE. |
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