| 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 | DUPEN LONG TERM EPIDURAL CATHETER |
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| Generic Name | CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
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| Applicant | C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,, UT 84116 |
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| PMA Number | P860064 |
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| Supplement Number | S009 |
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| Date Received | 01/15/1998 |
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| Decision Date | 01/26/1998 |
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| Withdrawal Date | 05/20/2020 |
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| Product Code |
LNY |
| Advisory Committee |
General Hospital |
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| Supplement Type | Real-Time Process |
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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 modifications to the instructions for use (IFU) for the DuPen Long Term Epidural Catheter and the DuPen Catheter Repair Kit. These six modifications are: 1) to delete references to resterilization of product; 2) to add a caution to the Repair Kit IFU to examine the package and not use or resterilize if package is damaged; 3) to add the prescription statement to the Repair Kit IFU; 4) To add international units of measurea nd general international requirements; 5) To add a general biohazard statement concerning handling of product after use to the IFUs and product labels; and 6) to add an international symbol (explained in the device IFU) tot he external catheter sleeve "Attention, See Instructions for Use." |
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