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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 NameMEDTRONIC SYNCHROMED INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS051
Date Received04/29/2002
Decision Date05/14/2002
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 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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