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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.
 
DevicePORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
Generic NameCATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
ApplicantSmiths Medical Asd, Inc.
1265 Grey Fox Rd.
St. Paul, MN 55112
PMA NumberP900052
Supplement NumberS008
Date Received09/07/1999
Decision Date09/23/1999
Withdrawal Date12/26/2018
Product Code LNY 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The 30-day Notice requested a manufacturing process change for the Port-A-Cath(R) Epidural Implantable Access System and for the Port-A-Cath(R)II Epidural Low Profile(TM) Implantable Access System. This change would allow the use of an automated turbidometric assay method for determination of pyrogens using the LAL-5000 System with PYROS Software.
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