PMA P830063S003
- Device
- GAMBRO PLASMAFILTER, PF2000N
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S003
- Product code
- MDP
- Decision date
- 2000-11-20
- Classification
- Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Approval order statement
- APPROVAL TO 1) EXPAND THE INSTRUCTIONS FOR USE (IFUS) TO PERMIT THE BLOOD FLOW DIRECTION DURING USE TO BE OPPOSITE TO THE DIRECTION OF FLOW OF THE RINSING AND PRIMING SOLUTIONS, AND TO 2) REMOVE THE BLOOD FLOW DIRECTION ARROW FROM THE DEVICE LABEL.
Current openFDA PMA Record#
- Device
- GAMBRO PLASMAFILTER, PF2000N
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S003
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2000-11-20
- Decision code
- APPR
- Date received
- 2000-10-31
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO 1) EXPAND THE INSTRUCTIONS FOR USE (IFUS) TO PERMIT THE BLOOD FLOW DIRECTION DURING USE TO BE OPPOSITE TO THE DIRECTION OF FLOW OF THE RINSING AND PRIMING SOLUTIONS, AND TO 2) REMOVE THE BLOOD FLOW DIRECTION ARROW FROM THE DEVICE LABEL.