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 | MEDTRONIC SYNCHROMED INFUSION SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S051 |
Date Received | 04/29/2002 |
Decision Date | 05/14/2002 |
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 |
Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES TO INTRATHECAL CATHETER MODEL 8711: 1) ADDITION OF NUMERICAL MARKINGS (IN CM) ON THE CATHETER TUBING, 2) CHANGE IN V-WING ANCHOR MATERIAL FOR IMPROVED VISIBILITY, 3) REMOVAL OF PROXIMAL ANCHOR; TUNNELING ROD TIPS AND WRENCH FROM THE CATHETER KIT, AND 4) UPDATE MODEL 8711 TECHNICAL MANUAL TO PROVIDE DETAILED INSTRUCTIONS AND CAUTIONS. |
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