PMA P800036S036

Device
INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP
Applicant
Intera Oncology
PMA number
P800036
Supplement
S036
Product code
LKK
Decision date
2006-06-23
Generic name
Pump, infusion, implanted, programmable
Approval order statement
APPROVAL FOR A MANUFACTURING SITE AT CODMAN & SHURTLEFF, INC.RAYNHAM, MASSACHUSETTS.

Current openFDA PMA Record#

Device
INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP
Applicant
Intera Oncology
PMA number
P800036
Supplement
S036
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2006-06-23
Decision code
APPR
Date received
2006-04-21
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Express GMP Supplement
Approval order statement
APPROVAL FOR A MANUFACTURING SITE AT CODMAN & SHURTLEFF, INC.RAYNHAM, MASSACHUSETTS.