PMA P050038S036

Device
Arista AH Absorbable Hemostatic
Applicant
Davol, Inc.
PMA number
P050038
Supplement
S036
Product code
LMG
Decision date
2020-09-25
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
Approval for the addition of a foreign matter inspection for Arista AH Absorbable Hemostatic Particles.

Current openFDA PMA Record#

Device
Arista AH Absorbable Hemostatic
Applicant
Davol, Inc.
PMA number
P050038
Supplement
S036
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2020-09-25
Decision code
APPR
Date received
2020-08-26
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the addition of a foreign matter inspection for Arista AH Absorbable Hemostatic Particles.