PMA P890055S018

Device
CODMAN SERIES 3000 IMPLANTABLE INFUSION PUMPS
Applicant
Intera Oncology
PMA number
P890055
Supplement
S018
Product code
LKK
Decision date
2004-03-25
Classification
Pump, Infusion, Implanted, Programmable
Generic name
Pump, infusion, implanted, programmable
Approval order statement
APPROVAL FOR THE FOLLOWING: MINOR DESIGN AND MATERIAL MODIFICATIONS TO THE CONNECTOR; ADDITION OF A SILICONE STRAIN RELIEF SLEEVE; AND MINOR DESIGN AND MATERIAL MODIFICATIONS TO THE ANCHORS.

Current openFDA PMA Record#

Device
CODMAN SERIES 3000 IMPLANTABLE INFUSION PUMPS
Applicant
Intera Oncology
PMA number
P890055
Supplement
S018
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2004-03-25
Decision code
APPR
Date received
2004-03-22
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE FOLLOWING: MINOR DESIGN AND MATERIAL MODIFICATIONS TO THE CONNECTOR; ADDITION OF A SILICONE STRAIN RELIEF SLEEVE; AND MINOR DESIGN AND MATERIAL MODIFICATIONS TO THE ANCHORS.