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 |
Generic Name | CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
Applicant | C.R. Bard, Inc. 605 N 5600 W SALT LAKE CITY, UT 84116 |
PMA Number | P860064 |
Supplement Number | S009 |
Date Received | 01/15/1998 |
Decision Date | 01/26/1998 |
Withdrawal Date
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05/20/2020 |
Product Code |
LNY |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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