Prismaflex TPE2000 Set
FDA premarket approval P830063/S012 · decided 2019-09-18
Approval details
- PMA number
- P830063
- Supplement
- S012
- Supplement type
- Real-Time Process
- 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
- 2019-06-27
- Decision date
- 2019-09-18
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- Approval for the use of the Prismaflex TPE2000 Set with the PrisMax Control Unit (Version 2) and modifications to the Instructions for Use.
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