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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.
 
DevicePORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Namecatheter, percutaneous, long term, intraspinal
Applicant
SMITHS MEDICAL ASD, INC.
1265 grey fox road
st. paul, MN 55112
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 - manufacturer/sterilizer/packager/supplier
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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