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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.
 
DevicePORT-A-CATH(R) INTRASPINAL IMPLANTABLE ACCESS SYST
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 NumberS002
Date Received06/28/1994
Decision Date10/13/1995
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a sterilization process chage from beta irradiation to ethylene oxide gas, packaging changes to a inner and outer tray configuration with a shelf carton and removal (per our guidance) of the shelf-life sterility dating for the port-a-cath intraspinal implantable access system.
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