PMA P830063S022

Device: PRISMAFLEX TPE2000 SET
Applicant: Vantive US Healthcare, LLC
PMA number: P830063
Supplement: S022
Product code: MDP
Decision date: 2022-03-31
Generic name: Separator for therapeutic purposes, membrane automated blood cell/plasma
Approval order statement: Sponsor proposed removal of visual inspection of two components at their Tunisia plant. The risk assessment and the quality report support this request.

Current openFDA PMA Record#

Device: PRISMAFLEX TPE2000 SET
Applicant: Vantive US Healthcare, LLC
PMA number: P830063
Supplement: S022
Product code: MDP
Generic name: Separator for therapeutic purposes, membrane automated blood cell/plasma
Decision date: 2022-03-31
Decision code: OK30
Date received: 2022-03-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Sponsor proposed removal of visual inspection of two components at their Tunisia plant. The risk assessment and the quality report support this request.