PMA P890055S005

Device: FLEX TIP INTRASPINAL KIT, CATALOG AP-07008
Applicant: Intera Oncology
PMA number: P890055
Supplement: S005
Product code: LKK
Decision date: 1998-12-23
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Approval for the Flex tip Plus Intraspinal Catheter Kit, Catalog AP-07008. This Catheter Kit will be used with the model 3000 Implantable Pump with Bolus Safety Valve for intraspinal delivery of preservative free morphine to patients with chronic intractable pain.

Current openFDA PMA Record#

Device: FLEX TIP INTRASPINAL KIT, CATALOG AP-07008
Applicant: Intera Oncology
PMA number: P890055
Supplement: S005
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 1998-12-23
Decision code: APPR
Date received: 1997-09-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Flex tip Plus Intraspinal Catheter Kit, Catalog AP-07008. This Catheter Kit will be used with the model 3000 Implantable Pump with Bolus Safety Valve for intraspinal delivery of preservative free morphine to patients with chronic intractable pain.