PMA P890055S012
- Device
- ARROW OR PUMP HEATER & AP-07009 FLEX TIP PLUS INTRASPINAL KIT
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S012
- Product code
- LKK
- Decision date
- 2001-04-24
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR THE ADDITION OF: 1) AN OR PUMP HEATER (AP-09100) AND DRAPE (AP-09150) AS AN OPTION TO THE TRADITIONAL WATER BATH; 2) A MICROPIPETTE OR PREP KIT (AP-07004) FOR THE MEASUREMENT OF FLOW FROM THE IMPLANTABLE PUMP PRIOR TO IMPLANTATION; AND 3) ACCESSORIES TO THE INTRASPINAL KIT (AP-07009), INCLUDING AN ADDITIONAL NEEDLE AND BOTH WINGED AND TRADITIONAL CATHETER ANCHORS.
Current openFDA PMA Record#
- Device
- ARROW OR PUMP HEATER & AP-07009 FLEX TIP PLUS INTRASPINAL KIT
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S012
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2001-04-24
- Decision code
- APPR
- Date received
- 2001-04-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF: 1) AN OR PUMP HEATER (AP-09100) AND DRAPE (AP-09150) AS AN OPTION TO THE TRADITIONAL WATER BATH; 2) A MICROPIPETTE OR PREP KIT (AP-07004) FOR THE MEASUREMENT OF FLOW FROM THE IMPLANTABLE PUMP PRIOR TO IMPLANTATION; AND 3) ACCESSORIES TO THE INTRASPINAL KIT (AP-07009), INCLUDING AN ADDITIONAL NEEDLE AND BOTH WINGED AND TRADITIONAL CATHETER ANCHORS.