PMA P050038S044
- Device
- Arista™ AH
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S044
- Product code
- LMG
- Decision date
- 2026-07-15
- Classification
- General, Plastic Surgery
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- updated water system equipment for the Woburn, MA manufacturing site
Current openFDA PMA Record#
- Device
- Arista™ AH
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S044
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2026-07-15
- Decision code
- OK30
- Date received
- 2026-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updated water system equipment for the Woburn, MA manufacturing site