PMA P890055S003
- Device
- CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S003
- Product code
- LKK
- Decision date
- 1997-09-22
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for the intraspinal delivery of preservative free morphine for patient with intractable chronic pain.
Current openFDA PMA Record#
- Device
- CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S003
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 1997-09-22
- Decision code
- APPR
- Date received
- 1997-02-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the intraspinal delivery of preservative free morphine for patient with intractable chronic pain.