PMA P990034S006
- Device
- ISOMED IMPLANTABLE PUMP SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P990034
- Supplement
- S006
- Product code
- LKK
- Decision date
- 2006-03-22
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR REVISED LABELING FOR THE MANUALS FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- ISOMED IMPLANTABLE PUMP SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P990034
- Supplement
- S006
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2006-03-22
- Decision code
- APPR
- Date received
- 2005-12-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED LABELING FOR THE MANUALS FOR THE DEVICE.