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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(R) INTRASPINAL IMPLANTABLE ACCESS SYST
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Namelong term epidural access system
ApplicantSIMS DELTEC, INC.
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 - other
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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