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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSYNCHROMED IMPLANTABLE INFUSION PUMP SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS046
Date Received06/18/2001
Decision Date06/29/2001
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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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