FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Lipoprotein, Low Density, Removal
PMA: P940016
·
Decision Sep 19, 1997
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Lipoprotein, Low Density, Removal
- Trade Name
- H.E.L.P. SYSTEM
- PMA Number
- P940016
- 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
- September 19, 1997
- Date Received
- June 1, 1994
- Expedited Review
- N
- Docket Number
- 98M-0138
Advisory Committee Statement
Approval for the H.E.L.P. System. The device is a low density lipoprotein cholesterol (LDL-C) apheresis system, indicated for use in perofrming LDL-C apheresis to acutely remove LDL-C from the plasma of high risk patient populations for whom diet has been ineffective or not tolerated.
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 |