| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST |
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| Classification Name | catheter, percutaneous, long term, intraspinal |
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| Generic Name | long term epidural access system |
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| Applicant | SIMS DELTEC, INC. |
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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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| Product Code | |
| Advisory Committee |
General Hospital |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - component |
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| Expedited Review Granted? | No |
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| Combination Product |
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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