PMA P890055S025

Device: SURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950)
Applicant: Intera Oncology
PMA number: P890055
Supplement: S025
Product code: LKK
Decision date: 2008-10-10
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR: 1) A NEW MANUFACTURING FACILITY, CODMAN NEUROSCIENCES, SARL, LELOCLE, SWITZERLAND AND 2) THE ADDITIONAL DEVICE ACCESSORIES FOR THE CODMAN 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP ¿ SURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950).

Current openFDA PMA Record#

Device: SURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950)
Applicant: Intera Oncology
PMA number: P890055
Supplement: S025
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2008-10-10
Decision code: APPR
Date received: 2007-12-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR: 1) A NEW MANUFACTURING FACILITY, CODMAN NEUROSCIENCES, SARL, LELOCLE, SWITZERLAND AND 2) THE ADDITIONAL DEVICE ACCESSORIES FOR THE CODMAN 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP ¿ SURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950).