PMA N17600S023

Device
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FOUR FAMILY
Applicant
Davol Inc., Sub. C. R. Bard, Inc.
PMA number
N17600
Supplement
S023
Product code
LMF
Decision date
2005-10-06
Classification
Agent, Absorbable Hemostatic, Collagen Based
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
MANUFACTURING PROCESS CHANGES FOR THE AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILIES OF DEVICES.

Current openFDA PMA Record#

Device
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FOUR FAMILY
Applicant
Davol Inc., Sub. C. R. Bard, Inc.
PMA number
N17600
Supplement
S023
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2005-10-06
Decision code
OK30
Date received
2005-09-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MANUFACTURING PROCESS CHANGES FOR THE AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILIES OF DEVICES.