- Device
- Prismaflex TPE2000 Set
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S015
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2020-03-25
- Decision code
- APPR
- Date received
- 2020-02-24
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the following changes in the instructions for use:1) A labeling change to align the sterile symbol to current sterile fluid path description in the instructions for use of the Prismaflex TPE2000 set; and2) The addition of the following warning statement: Use only drugs compatible with plastics listed in the specifications section. Some plastics can be incompatible with drugs when in contact with solutions with pH > 10.