PMA N17600S041

Device: AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT)
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S041
Product code: LMF
Decision date: 2025-02-18
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: approval for changes made to the Avitene product family’s labeling, including the instructions for use (IFU), during the European Union (EU) Medical Device Regulation (MDR) transition.

Current openFDA PMA Record#

Device: AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT)
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S041
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2025-02-18
Decision code: APPR
Date received: 2024-11-12
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for changes made to the Avitene product family’s labeling, including the instructions for use (IFU), during the European Union (EU) Medical Device Regulation (MDR) transition.