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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 EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
Generic NameCATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
ApplicantSMITHS MEDICAL ASD, INC.
1265 Grey Fox Road
St. Paul, MN 55112
PMA NumberP900052
Supplement NumberS012
Date Received10/30/2002
Decision Date12/17/2002
Withdrawal Date 12/26/2018
Product Code LNY 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR: 1) THE ADDITION OF PROCEDURAL ACCESSORIES TO THE PORT-A-CATH EPIDURAL SYSTEM KIT, 2) AN ALTERNATE PACKAGING CONFIGURATION AND 3) CHANGE IN ETHYLENE OXIDE RESIDUAL LIMITS. THESE ADDED ACCESSORIES ARE EXACTLY THE SAME AS THOSE DESCRIBED IN P900052/S005 FOR PORT-A-CATH II EPIDURAL LOW-PROFILE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH EPIDURAL SYSTEM KITS.
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