FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
PMA: P830063
·
Supplement: S009
·
Decision Dec 22, 2016
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
- Trade Name
- PRISMAFLEX TPE 2000 WITH PLASMAFILTER PF2000N
- PMA Number
- P830063
- Supplement Number
- S009
- Device Class
- FDA Class 3
- Product Code
- MDP
- Generic Name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 22, 2016
- Date Received
- December 2, 2016
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Change to the equipment used to extract oils from the fiber bundles.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MDP | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma | FDA class 3 | Unknown |