Prismaflex TPE2000
FDA premarket approval P830063/S025 · decided 2023-03-29
Approval details
- PMA number
- P830063
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Prismaflex TPE2000
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 2023-03-02
- Decision date
- 2023-03-29
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- Changing the transfer of the molding activity of the female luer lock 5.5 (current part number: 9200973400, new part number: 60023196) that is present on the Prismaflex TPE 2000 set, from HMC, a third-party supplier to the Baxter manufacturing plant Malta.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| AK 98 Dialysis Machine (955607) (K250508) | Vantive US Healthcare, LLC | 2025-08-01 |