PMA P050038S042
- Device
- Arista AH
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S042
- Product code
- LMG
- Decision date
- 2024-11-04
- Classification
- General, Plastic Surgery
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- change in the raw material potato starch in the manufacturing of Arista AH
Current openFDA PMA Record#
- Device
- Arista AH
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S042
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2024-11-04
- Decision code
- APPR
- Date received
- 2024-05-03
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change in the raw material potato starch in the manufacturing of Arista AH