- Device
- Avitene Flowable Collagen Hemostat
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- PMA number
- N17600
- Supplement
- S043
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2025-06-10
- Decision code
- APPR
- Date received
- 2025-03-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for removal of the neurological exclusion from the Avitene™ Flowable Collagen Hemostat indications for use.