Catheter, Percutaneous, Long Term, Intraspinal
Basic Information
- Device Name
- Catheter, Percutaneous, Long Term, Intraspinal
- Trade Name
- DUPEN LONG TERM EPIDURAL CATHETER
- PMA Number
- P860064
- Supplement Number
- S009
- Device Class
- FDA Class 3
- Product Code
- LNY
- Generic Name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Medical Specialty
- Unknown
- Advisory Committee
- General Hospital
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 26, 1998
- Date Received
- January 15, 1998
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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."
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNY | Catheter, Percutaneous, Long Term, Intraspinal | FDA class 3 | Unknown |