PMA P050038

Device: Arista™ AH
Applicant: Davol, Inc.
PMA number: P050038
Supplement: S039
Product code: LMG
Decision date: 2026-04-29
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: installation of new equipment to automate the filling/weighing and label-application processes, as well as for the upgrade of the HVAC system for the cleanroom used for Arista AH packaging processes

Current openFDA PMA Record#

Device: Arista™ AH
Applicant: Davol, Inc.
PMA number: P050038
Supplement: S043
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2026-04-29
Decision code: OK30
Date received: 2026-03-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: installation of new equipment to automate the filling/weighing and label-application processes, as well as for the upgrade of the HVAC system for the cleanroom used for Arista AH packaging processes