PMA P810006S025

Device
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Applicant
Integra LifeSciences Corporation
PMA number
P810006
Supplement
S025
Product code
LMF
Decision date
2006-12-19
Classification
Agent, Absorbable Hemostatic, Collagen Based
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
CHANGE IN MANUFACTURING EQUIPMENT USED IN THE COLLAGEN PURIFICATION PROCESS.

Current openFDA PMA Record#

Device
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Applicant
Integra LifeSciences Corporation
PMA number
P810006
Supplement
S025
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2006-12-19
Decision code
OK30
Date received
2006-11-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN MANUFACTURING EQUIPMENT USED IN THE COLLAGEN PURIFICATION PROCESS.