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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 NamePORT-A-CATH EPIDURAL SYSTEMS
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Nameepidural implantable access system
ApplicantDELTEC, INC.
PMA NumberP900052
Supplement NumberS009
Date Received09/11/2001
Decision Date10/01/2001
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Eliminate the inspection procedure on some incoming components used in the manufacture of the port-a-cath(r) epidural systems.
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