PMA P890055S050

Device
MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant
Intera Oncology
PMA number
P890055
Supplement
S050
Product code
LKK
Decision date
2013-09-23
Classification
Pump, Infusion, Implanted, Programmable
Generic name
Pump, infusion, implanted, programmable
Approval order statement
REMOVAL OF A DUPLICATE VISUAL INSPECTION PERFORMED ON TWO ACCESSORY COMPONENTS PACKAGED WITH THE MEDSTREAM INTRATHECAL CATHETER.

Current openFDA PMA Record#

Device
MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant
Intera Oncology
PMA number
P890055
Supplement
S050
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2013-09-23
Decision code
OK30
Date received
2013-08-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REMOVAL OF A DUPLICATE VISUAL INSPECTION PERFORMED ON TWO ACCESSORY COMPONENTS PACKAGED WITH THE MEDSTREAM INTRATHECAL CATHETER.