PMA P800036S031

Device
INFUSAID IMPLANTABLE INFUSION PUMP
Applicant
Intera Oncology
PMA number
P800036
Supplement
S031
Product code
LKK
Decision date
1996-12-23
Generic name
Pump, infusion, implanted, programmable
Approval order statement
APPROVAL FOR THE UNFUSAID(TM) 14G INTRASPINAL CATHETER KIT, AN ACCESSORY TO THE INFUSAID IMPLANTABLE INFUSION PUMP.

Current openFDA PMA Record#

Device
INFUSAID IMPLANTABLE INFUSION PUMP
Applicant
Intera Oncology
PMA number
P800036
Supplement
S031
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
1996-12-23
Decision code
APPR
Date received
1994-03-08
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR THE UNFUSAID(TM) 14G INTRASPINAL CATHETER KIT, AN ACCESSORY TO THE INFUSAID IMPLANTABLE INFUSION PUMP.