Prismaflex TPE2000 Set
FDA premarket approval P830063/S015 · decided 2020-03-25
Approval details
- PMA number
- P830063
- Supplement
- S015
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Prismaflex TPE2000 Set
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 2020-02-24
- Decision date
- 2020-03-25
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- 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.
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| Record | Firm | Date |
|---|---|---|
| AK 98 Dialysis Machine (955607) (K250508) | Vantive US Healthcare, LLC | 2025-08-01 |