PMA P050038S032

Device: Arista AH; Arista AH Absorbable Hemostat
Applicant: Davol, Inc.
PMA number: P050038
Supplement: S032
Product code: LMG
Decision date: 2019-01-24
Classification: Agent, Absorbable Hemostatic, Non-collagen Based
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: Approval for a new supplier of the subcomponent raw material HST (hydrolyzed starch technology) which is used in the manufacturing of the DSM-A (non-sterile powder) component of the Arista™ AH device. Additionally, the supplement includes an improvement in the test method for hydrolyzed starch characterization.

Current openFDA PMA Record#

Device: Arista AH; Arista AH Absorbable Hemostat
Applicant: Davol, Inc.
PMA number: P050038
Supplement: S032
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2019-01-24
Decision code: APPR
Date received: 2018-08-01
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a new supplier of the subcomponent raw material HST (hydrolyzed starch technology) which is used in the manufacturing of the DSM-A (non-sterile powder) component of the Arista™ AH device. Additionally, the supplement includes an improvement in the test method for hydrolyzed starch characterization.