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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 & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS
Generic NameCATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
ApplicantSMITHS MEDICAL ASD, INC.
1265 Grey Fox Road
St. Paul, MN 55112
PMA NumberP900052
Supplement NumberS014
Date Received12/08/2006
Decision Date08/28/2007
Withdrawal Date 12/26/2018
Product Code LNY 
Advisory Committee General Hospital
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE IN-PROCESS MANUFACTURING PACKAGE INSPECTION PROCEDURE OF THE PORT-A-CATH EPIDURAL AND PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS. THE MODIFICATIONS TO THE IN-PROCESS POUCH SEAL INSPECTION INCLUDES: 1) FIVE TEST INTERVALS WILL BE PERFORMED OVER A SINGLE DAY VERSUS THREE TEST INTERVALS PER EACH MANUFACTURING JOB. 2) THE CURRENT FIVE POUCHES TESTED USING THE PULL TEST WILL BE REDUCED TO TWO POUCHES PER TEST PERIOD AND THE CURRENT TWO POUCHES INSPECTED USING HAND PEEL AND VISUAL VERIFICATION WILL BE INCREASED TO FIVE POUCHES PER TEST PERIOD. 3) THE RESULTS OF THE GAGE PULL TEST AND VISUAL INSPECTION WILL BE RECORDED IN THE INDIVIDUAL JOB FOLDER PER ESTABLISHED TEST INTERVAL. 4) THE POUCH SEALING PROCESS PARAMETER SETTINGS WILL CONTINUE TO BE RECORDED FOR EACH JOB AND EACH INSPECTION INTERVAL.
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