PMA P050038S030
- Device
- ARISTA AH ABSORBABLE HEMOSTAT
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S030
- Product code
- LMG
- Decision date
- 2016-12-12
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Approval of the removal of neurological exclusions from the Indications For Use and changes to the labeling.
Current openFDA PMA Record#
- Device
- ARISTA AH ABSORBABLE HEMOSTAT
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S030
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2016-12-12
- Decision code
- APPR
- Date received
- 2016-06-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval of the removal of neurological exclusions from the Indications For Use and changes to the labeling.