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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 NamePORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Nameepidural implantable access system
ApplicantSIMS DELTEC, INC.
PMA NumberP900052
Supplement NumberS008
Date Received09/07/1999
Decision Date09/23/1999
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 
The 30-day notice requested a manufacturing process change for the port-a-cath(r) epidural implantable access system and for the port-a-cath(r)ii epidural low profile(tm) implantable access system. This change would allow the use of an automated turbidometric assay method for determination of pyrogens using the lal-5000 system with pyros software.
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