PMA N17600S040
- Device
- Avitene Flowable Collagen Hemostat
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- PMA number
- N17600
- Supplement
- S040
- Product code
- LMF
- Decision date
- 2024-12-18
- Classification
- General, Plastic Surgery
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Approval for a change in materials of the pre-filled syringe in the AviteneTM Flowable Collagen Hemostat kit
Current openFDA PMA Record#
- Device
- Avitene Flowable Collagen Hemostat
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- PMA number
- N17600
- Supplement
- S040
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2024-12-18
- Decision code
- APPR
- Date received
- 2024-06-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in materials of the pre-filled syringe in the AviteneTM Flowable Collagen Hemostat kit