PMA N17600S027

Device: AVITENE ULTRAFOAM MICROFIBRILLAR COLLAGEN HEMOSTAT SPONGE
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S027
Product code: LMF
Decision date: 2013-06-27
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: REVISED LAL (ENDOTOXIN) TEST FOR THE AVITENE® ULTRAFOAM® MICROFIBRILLAR COLLAGEN HEMOSTAT SPONGE MANUFACTURED AT THE WOBURN MASSACHUSETTS SITE.

Current openFDA PMA Record#

Device: AVITENE ULTRAFOAM MICROFIBRILLAR COLLAGEN HEMOSTAT SPONGE
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S027
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2013-06-27
Decision code: OK30
Date received: 2013-05-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REVISED LAL (ENDOTOXIN) TEST FOR THE AVITENE® ULTRAFOAM® MICROFIBRILLAR COLLAGEN HEMOSTAT SPONGE MANUFACTURED AT THE WOBURN MASSACHUSETTS SITE.