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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
Generic NameCATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
ApplicantSmiths Medical Asd, Inc.
1265 Grey Fox Rd.
St. Paul, MN 55112
PMA NumberP900052
Supplement NumberS006
Date Received06/04/1998
Decision Date09/15/1998
Withdrawal Date12/26/2018
Product Code LNY 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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