Gambro Prismaflex TPE 2000 Set
FDA premarket approval P830063/S020 · decided 2022-01-27
Approval details
- PMA number
- P830063
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Gambro Prismaflex TPE 2000 Set
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 2021-11-09
- Decision date
- 2022-01-27
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- Approval for a change in the polyvinyl chloride (PVC) material used for the production of the joint connectors in the Prismaflex TPE2000 Set.
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