FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Lipoprotein, Low Density, Removal
PMA: P910018
·
Supplement: S039
·
Decision Jan 24, 2025
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
- S039
- Device Class
- FDA Class 3
- Product Code
- MMY
- Generic Name
- Lipoprotein, low density, removal
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 24, 2025
- Date Received
- July 31, 2024
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
approval for changes to the Indications for Use Statement and device labeling.
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 |