PMA P830063S026
- Device
- Gambro Prismaflex TPE 2000 Set
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S026
- Product code
- MDP
- Decision date
- 2023-10-27
- Classification
- Gastroenterology, Urology
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Approval order statement
- Removal of non-occlusivity test in the leak testing of the Prismaflex TPE 2000 Set
Current openFDA PMA Record#
- Device
- Gambro Prismaflex TPE 2000 Set
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S026
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2023-10-27
- Decision code
- OK30
- Date received
- 2023-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of non-occlusivity test in the leak testing of the Prismaflex TPE 2000 Set