PMA P830063S007
- Device
- GAMBRO PRISMAFLEX TPE 2000 SET
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S007
- Product code
- MDP
- Decision date
- 2015-06-26
- Classification
- Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Approval order statement
- CHANGE TO THE PYROGEN TEST METHOD (FROM RABBIT TEST TO KINETIC-CHROMOGENIC LAL TEST) USED FOR PRODUCT RELEASE OF PRISMAFLEX TPE 2000 SETS.
Current openFDA PMA Record#
- Device
- GAMBRO PRISMAFLEX TPE 2000 SET
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S007
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2015-06-26
- Decision code
- OK30
- Date received
- 2015-05-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE PYROGEN TEST METHOD (FROM RABBIT TEST TO KINETIC-CHROMOGENIC LAL TEST) USED FOR PRODUCT RELEASE OF PRISMAFLEX TPE 2000 SETS.