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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) INTRASPINAL IMPLANTABLE ACCESS SYST
Generic NameCATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
ApplicantSmiths Medical Asd, Inc.
1265 Grey Fox Rd.
St. Paul, MN 55112
PMA NumberP900052
Supplement NumberS002
Date Received06/28/1994
Decision Date10/13/1995
Withdrawal Date12/26/2018
Product Code LNY 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A STERILIZATION PROCESS CHAGE FROM BETA IRRADIATION TO ETHYLENE OXIDE GAS, PACKAGING CHANGES TO A INNER AND OUTER TRAY CONFIGURATION WITH A SHELF CARTON AND REMOVAL (PER OUR GUIDANCE) OF THE SHELF-LIFE STERILITY DATING FOR THE PORT-A-CATH INTRASPINAL IMPLANTABLE ACCESS SYSTEM
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