PMA P890055S009

Device: CONSTANT FLOW IMPLANTABLE INFUSION PUMP
Applicant: Intera Oncology
PMA number: P890055
Supplement: S009
Product code: LKK
Decision date: 2000-01-21
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Approval for adding the Drug Lioresal (Baclofen) to the list of drugs approved for use with the Model 3000-16 and Model 3000-50 Implantable Drug Delivery Pumps. Also, the label will clearly indicate that baclofen is stable for 44 days at 37C.

Current openFDA PMA Record#

Device: CONSTANT FLOW IMPLANTABLE INFUSION PUMP
Applicant: Intera Oncology
PMA number: P890055
Supplement: S009
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2000-01-21
Decision code: APPR
Date received: 1999-02-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for adding the Drug Lioresal (Baclofen) to the list of drugs approved for use with the Model 3000-16 and Model 3000-50 Implantable Drug Delivery Pumps. Also, the label will clearly indicate that baclofen is stable for 44 days at 37C.