PMA P830063S019
- Device
- Prismaflex TPE2000 Set
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S019
- Product code
- MDP
- Decision date
- 2021-06-24
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Approval order statement
- Transfer the production of some components of the Prismaflex TPE2000 set to alternate Baxter locations.
Current openFDA PMA Record#
- Device
- Prismaflex TPE2000 Set
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S019
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2021-06-24
- Decision code
- OK30
- Date received
- 2021-05-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer the production of some components of the Prismaflex TPE2000 set to alternate Baxter locations.