PMA N17600S038
- Device
- AviteneĀ Microfibrillar Collagen Hemostat
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- Product code
- LMF
- Decision date
- 2023-04-25
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Approval for the additional milling step of the AviteneTM bulk flour and hydration with sterile saline prior to use.
Current openFDA PMA Record
- Device
- AviteneĀ Microfibrillar Collagen Hemostat
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- PMA number
- N17600
- Supplement
- S038
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2023-04-25
- Decision code
- APPR
- Date received
- 2022-08-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the additional milling step of the AviteneTM bulk flour and hydration with sterile saline prior to use.