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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePORT-A-CATH(R) EPIDURAL 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 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/material
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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