PMA P890055S008

Device: FLEX TIP PLUS INTRASPINAL CATHETER KIT(CATHETER CONNECTOR)
Applicant: Intera Oncology
PMA number: P890055
Supplement: S008
Product code: LKK
Decision date: 1999-12-10
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order 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.

Current openFDA PMA Record#

Device: FLEX TIP PLUS INTRASPINAL CATHETER KIT(CATHETER CONNECTOR)
Applicant: Intera Oncology
PMA number: P890055
Supplement: S008
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 1999-12-10
Decision code: APPR
Date received: 1999-02-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.