PMA P830063S002
- Device
- GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF2000N
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S002
- Product code
- MDP
- Decision date
- 2002-08-28
- 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 MODIFICATIONS TO THE REQUIREMENTS OF THE POST-MARKET STUDY FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF2000N
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S002
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2002-08-28
- Decision code
- APPR
- Date received
- 2000-01-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE REQUIREMENTS OF THE POST-MARKET STUDY FOR THE DEVICE.