PMA P830063

Device: Prismaflex TPE2000 Set
Applicant: Vantive US Healthcare, LLC
PMA number: P830063
Supplement: S024
Product code: MDP
Decision date: 2026-03-13
Generic name: Separator for therapeutic purposes, membrane automated blood cell/plasma
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

Current openFDA PMA Record#

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