PMA P860064S009
- Device
- DUPEN LONG TERM EPIDURAL CATHETER
- Applicant
- C.R. Bard, Inc.
- PMA number
- P860064
- Supplement
- S009
- Product code
- LNY
- Decision date
- 1998-01-26
- Classification
- Catheter, Percutaneous, Long Term, Intraspinal
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- 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."
Current openFDA PMA Record#
- Device
- DUPEN LONG TERM EPIDURAL CATHETER
- Applicant
- C.R. Bard, Inc.
- PMA number
- P860064
- Supplement
- S009
- Product code
- LNY
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Decision date
- 1998-01-26
- Decision code
- APPR
- Date received
- 1998-01-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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."