PRISMAFLEX TPE2000
FDA premarket approval P830063/S014 · decided 2019-12-11
Approval details
- PMA number
- P830063
- Supplement
- S014
- 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
- 2019-11-15
- Decision date
- 2019-12-11
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- Addition of an anti-error tubing connector feature to the support plate of the Prismaflex TPE2000 Set and a move of the manufacturing of several set components (e.g., striped tubes, luer components, and injection sites) to Marsa, Malta from Medolla, Italy.
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| AK 98 Dialysis Machine (955607) (K250508) | Vantive US Healthcare, LLC | 2025-08-01 |