- Device
- Gambro Prismaflex TPE 2000 Set
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S024
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2022-11-08
- Decision code
- OK30
- Date received
- 2022-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of the manufacturing process of the Bubble up and the Bubble down components of the Prismaflex TPE2000 set to the Borla supplier manufacturing facility.