PMA N17600S046
- Device
- Avitene™ Flowable Collagen Hemostat
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- PMA number
- N17600
- Supplement
- S046
- Product code
- LMF
- Decision date
- 2026-05-11
- Classification
- General, Plastic Surgery
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- a new vacuum oven for the Avitene™ Flowable product at the Woburn, MA manufacturing facility
Current openFDA PMA Record#
- Device
- Avitene™ Flowable Collagen Hemostat
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- PMA number
- N17600
- Supplement
- S046
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2026-05-11
- Decision code
- OK30
- Date received
- 2026-04-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new vacuum oven for the Avitene™ Flowable product at the Woburn, MA manufacturing facility