FLEX TIP PLUS INTRASPINAL CATHETER KIT(CATHETER CONNECTOR)
FDA premarket approval P890055/S008 · decided 1999-12-10
Approval details
- PMA number
- P890055
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FLEX TIP PLUS INTRASPINAL CATHETER KIT(CATHETER CONNECTOR)
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 1999-02-05
- Decision date
- 1999-12-10
- Days to decision
- 308 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Approval for the following modifications of the existing Flex Tip Plus Intraspinal Catheter Kit catalog #AP-07008: 1) Addition of a "locking feature" to the current catheter connector design to prevent the connector from being inadvertently opened. 2) Addition of a "stylet" to the kit. 3) Replacement of the blunt flushing needle with the "Snap Lock Flushing Adapter". 4) Addition of the "threading guide" and the "attachable wing hub". 5) Increasing the Flex Tip Plus Intraspinal Catheter length.
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