- Device
- Prismaflex TPE2000 Set
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S030
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2026-03-13
- Decision code
- APPR
- Date received
- 2025-12-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Extend Prismaflex TPE2000 Set EO sterilization to STERLAB new supplier (scope of the P830063/A013 notification) for the Chambers #11 and #14, increase the sterilization load by changing palletization configuration from 4 layers of boxes to 5 layers of boxes per pallet at STERLAB, and qualify a new EO supplier STERISERVICES, for the Chamber ATC011