PMA P050038S037

Device: Arista AH Absorbable Hemostatic Particles
Applicant: Davol, Inc.
PMA number: P050038
Supplement: S037
Product code: LMG
Decision date: 2021-07-06
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: Approval for an additional filling and packaging site for the Arista AH Absorbable Hemostatic device at the Davol, Inc. Woburn, Massachusetts manufacturing site.

Current openFDA PMA Record#

Device: Arista AH Absorbable Hemostatic Particles
Applicant: Davol, Inc.
PMA number: P050038
Supplement: S037
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2021-07-06
Decision code: APPR
Date received: 2020-10-02
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an additional filling and packaging site for the Arista AH Absorbable Hemostatic device at the Davol, Inc. Woburn, Massachusetts manufacturing site.