FDA PMA FDA Class 3 Approved 🇺🇸 United States

Agent, Absorbable Hemostatic, Collagen Based

PMA: P800002 · Supplement: S004 · Decision Jan 17, 1984
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
S004
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
January 17, 1984
Date Received
August 30, 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
LMF Agent, Absorbable Hemostatic, Collagen Based