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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 EPIDURAL IMPLANTABLE ACCESS SYSTEM
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Nameepidural implantable access system
ApplicantDELTEC, INC.
PMA NumberP900052
Supplement NumberS010
Date Received10/31/2001
Decision Date06/11/2002
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the manufacturing facility located at the finishing/polishing facility located at eltronic, coon rapids, minnesota.
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