PMA P050038S034
- Device
- Arista AH Absorbable Hemostat
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S034
- Product code
- LMG
- Decision date
- 2019-11-19
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Qualification of a new production line identical to the first, extended holding time in the hoppers, and reduction in labeling (no content changes).
Current openFDA PMA Record#
- Device
- Arista AH Absorbable Hemostat
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S034
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2019-11-19
- Decision code
- OK30
- Date received
- 2019-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of a new production line identical to the first, extended holding time in the hoppers, and reduction in labeling (no content changes).