FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Pump, Infusion, Implanted, Programmable
PMA: P890055
·
Decision Mar 11, 1996
Classifications
1
FEI Numbers
18
Registration Numbers
18
Basic Information
- Device Name
- Pump, Infusion, Implanted, Programmable
- Trade Name
- MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM
- PMA Number
- P890055
- Device Class
- FDA Class 3
- Product Code
- LKK
- Generic Name
- Pump, infusion, implanted, programmable
- Medical Specialty
- Unknown
- Advisory Committee
- General Hospital
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 11, 1996
- Date Received
- September 28, 1989
- Expedited Review
- N
- Docket Number
- 96M-0239
Advisory Committee Statement
APPROVAL FOR MODEL 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP
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 |
|---|---|---|---|
| LKK | Pump, Infusion, Implanted, Programmable | FDA class 3 | Unknown |