FDA PMA FDA Class 3 Approved 🇺🇸 United States

Agent, Absorbable Hemostatic, Collagen Based

PMA: P810006 · Supplement: S002 · Decision Apr 12, 1982
Classifications
1
FEI Numbers
35
Registration Numbers
35

Basic Information

Device Name
Agent, Absorbable Hemostatic, Collagen Based
Trade Name
COLLASTAT
PMA Number
P810006
Supplement Number
S002
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
April 12, 1982
Date Received
February 11, 1982
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