| 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. |
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| Device | PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST |
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| Generic Name | CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
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| Applicant | Smiths Medical Asd, Inc.
1265 Grey Fox Rd.
St. Paul, MN 55112 |
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| PMA Number | P900052 |
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| Supplement Number | S005 |
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| Date Received | 04/07/1998 |
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| Decision Date | 10/20/1998 |
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| Withdrawal Date | 12/26/2018 |
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| Product Code |
LNY |
| Advisory Committee |
General Hospital |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for 1) The following design modifications to the current, legally marketed PORT-A-CATH(R) II: a smaller (25.4mm. based diameter, a 12.7mm. height, and a 8.9mm. septum diameter), lighter weight (5.0 grams) portal with a titanium outlet tube; a filter change from a 60 micron stainless steel(SS) screen to a 20 micron sintered titanium filter; and a change to a titanium locking wing portion of the CATH-SHIELD catheter connector; and 2) the labeling revisions as delineated in the first amendment dated 6/23/98. |
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