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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 NumberS006
Date Received06/04/1998
Decision Date09/15/1998
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the postapproval protocol to allow the use of anesthetics or analgesics approved for epidural delivery when toxicity symptoms related to the use of preservative-free morphine develop or if there is inadequate pain relief.
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