FDA.reportPublic FDA data

PMA P800002S025

Device
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and EndoAvitene
Applicant
C.R. Bard, Inc.
PMA number
P800002
Supplement
S025
Product code
LMF
Decision date
2019-06-21
Classification
Agent, Absorbable Hemostatic, Collagen Based
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
Change to in-process manufacturing test methods and in process bioburden monitoring specifications of the Avitene bulk flour component prior to sterilization.

Current openFDA PMA Record#

Device
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and EndoAvitene
Applicant
C.R. Bard, Inc.
PMA number
P800002
Supplement
S025
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2019-06-21
Decision code
OK30
Date received
2019-05-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to in-process manufacturing test methods and in process bioburden monitoring specifications of the Avitene bulk flour component prior to sterilization.