PMA P830063S008
- Device
- GAMBRO PRISMAFLEX TPE 2000 SET
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S008
- Product code
- MDP
- Decision date
- 2015-11-12
- Classification
- Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Approval order statement
- APPROVAL FOR A LABELING CHANGE TO ADDRESS COMPLAINTS RELATED TO LUER CONNECTOR CRACKS.
Current openFDA PMA Record#
- Device
- GAMBRO PRISMAFLEX TPE 2000 SET
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S008
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2015-11-12
- Decision code
- APPR
- Date received
- 2015-10-13
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A LABELING CHANGE TO ADDRESS COMPLAINTS RELATED TO LUER CONNECTOR CRACKS.