PMA N17600S042

Device: Avitene Microfibrillar Collagen Hemostat
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S042
Product code: LMF
Decision date: 2025-03-13
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: for a new tray sealer for the Ultrafoam product line and to change the sampling plan for incoming foil pouches for all Avitene products

Current openFDA PMA Record#

Device: Avitene Microfibrillar Collagen Hemostat
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S042
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2025-03-13
Decision code: OK30
Date received: 2025-02-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for a new tray sealer for the Ultrafoam product line and to change the sampling plan for incoming foil pouches for all Avitene products