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PMA P800002S024

Device
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT
Applicant
C.R. Bard, Inc.
PMA number
P800002
Supplement
S024
Product code
LMF
Decision date
2018-12-26
Classification
Agent, Absorbable Hemostatic, Collagen Based
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
Implement an autotitrator system to measure the in-process determination of acid content per gram of collagen and the in-process specification for residual hydrochloric acid content after acidification.

Current openFDA PMA Record#

Device
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT
Applicant
C.R. Bard, Inc.
PMA number
P800002
Supplement
S024
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2018-12-26
Decision code
OK30
Date received
2018-12-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implement an autotitrator system to measure the in-process determination of acid content per gram of collagen and the in-process specification for residual hydrochloric acid content after acidification.