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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceSYNCHROMED IMPLANTABLE INFUSION PUMP SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS046
Date Received06/18/2001
Decision Date06/29/2001
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THREE NEW PUMP CONNECTOR DESIGNS AND A CHANGE IN THE MODEL 8709 CATHETER KIT CONTENTS: 1) NEW MODEL 8575 400 PUMP CONNECTOR FOR THE MODEL 8709 INTRATHECAL CATHETER. 2) NEW MODEL 8577 900 PUMP CONNECTOR FOR THE MODEL 8709 INTRATHECAL CATHETER. 3) NEW MODEL 8576 900 PUMP CONNECTOR FOR USE WITH THE MODEL 8700A AND MODEL 8700V VASCULAR CATHETERS. 4) NEW MODEL 8709 CATHETER KITS WILL REPLACE THE CURRENT CATHETERS WITH THE 400 MODEL 8575 PUMP CONNECTOR FOR SYNCHROMED PUMPS WITH A CAP (CATHETER ACCESS PORT), OR A MODEL 8577 900 PUMP CONNECTOR FOR A SYNCHROMED PUMP WITHOUT A CAP.
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