FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Agent, Absorbable Hemostatic, Collagen Based
PMA: P800002
·
Supplement: S005
·
Decision Nov 17, 1983
Classifications
1
FEI Numbers
35
Registration Numbers
35
Basic Information
- Device Name
- Agent, Absorbable Hemostatic, Collagen Based
- Trade Name
- MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB
- PMA Number
- P800002
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- LMF
- Generic Name
- Agent, absorbable hemostatic, collagen based
- Regulation Number
- 878.4490
- Medical Specialty
- General, Plastic Surgery
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 17, 1983
- Date Received
- October 11, 1983
- Expedited Review
- N
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 |
|---|---|---|---|
| LMF | Agent, Absorbable Hemostatic, Collagen Based | FDA class 3 | General, Plastic Surgery |