PMA P050038S039
- Device
- Arista AH Absorbable Hemostatic Particles Device
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S039
- Product code
- LMG
- Decision date
- 2021-08-20
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Approval for replacement of an in vitro hemostasis specification and test method used for lot release testing.
Current openFDA PMA Record#
- Device
- Arista AH Absorbable Hemostatic Particles Device
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S039
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2021-08-20
- Decision code
- APPR
- Date received
- 2021-05-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for replacement of an in vitro hemostasis specification and test method used for lot release testing.