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PMA P050038S035

Device
Arista AH Absorbable Hemostatic Particles
Applicant
Davol, Inc.
PMA number
P050038
Supplement
S035
Product code
LMG
Decision date
2020-04-29
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
Approval for a change to the instructions for use on the cardiotomy filter size range to include a 20-40 micron size range for autologous blood salvage systems compatible with the device.

Current openFDA PMA Record#

Device
Arista AH Absorbable Hemostatic Particles
Applicant
Davol, Inc.
PMA number
P050038
Supplement
S035
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2020-04-29
Decision code
APPR
Date received
2020-02-24
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change to the instructions for use on the cardiotomy filter size range to include a 20-40 micron size range for autologous blood salvage systems compatible with the device.