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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) EPIDURAL IMPLANTABLE ACCESS SYST
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Namelong term epidural access system
ApplicantSIMS DELTEC, INC.
PMA NumberP900052
Supplement NumberS005
Date Received04/07/1998
Decision Date10/20/1998
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) the following design modifications to the current, legally marketed port-a-cath(r) ii: a smaller (25. 4mm. Based diameter, a 12. 7mm. Height, and a 8. 9mm. Septum diameter), lighter weight (5. 0 grams) portal with a titanium outlet tube; a filter change from a 60 micron stainless steel(ss) screen to a 20 micron sintered titanium filter; and a change to a titanium locking wing portion of the cath-shield catheter connector; and 2) the labeling revisions as delineated in the first amendment dated 6/23/98.
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