PMA N17600S032

Device: Avitene Microfibrillar Collagen Hemostat (MCH) Flour, SyringeAvitene and UltraFoam
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S032
Product code: LMF
Decision date: 2019-06-21
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Change to in-process manufacturing test methods and in process bioburden monitoring specifications of the Avitene bulk flour component prior to sterilization.

Current openFDA PMA Record#

Device: Avitene Microfibrillar Collagen Hemostat (MCH) Flour, SyringeAvitene and UltraFoam
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S032
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2019-06-21
Decision code: OK30
Date received: 2019-05-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to in-process manufacturing test methods and in process bioburden monitoring specifications of the Avitene bulk flour component prior to sterilization.