FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Lipoprotein, Low Density, Removal
PMA: P910018
·
Supplement: S025
·
Decision Apr 12, 2018
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Lipoprotein, Low Density, Removal
- Trade Name
- Liposorber LA-15 System
- PMA Number
- P910018
- Supplement Number
- S025
- Device Class
- FDA Class 3
- Product Code
- MMY
- Generic Name
- Lipoprotein, low density, removal
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- April 12, 2018
- Date Received
- March 29, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Change to the bioburden recovery procedure of the sterilization process used for the SULFLUX® KP-05 plasma filter device, a component of the LIPOSORBER® LA-15 System.
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 |
|---|---|---|---|
| MMY | Lipoprotein, Low Density, Removal | FDA class 3 | Unknown |