PMA N12159S086

Device: SURGICEL™ Original Absorbable Hemostat, SURGICEL™ NU-KNIT Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat,
Applicant: ETHICON, Inc.
Product code: LMG
Decision date: 2022-07-26
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: Approval for labeling changes for SURGICEL Original Absorbable Hemostat, SURGICEL NU-KNIT Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, SURGICEL SNoW Absorbable Hemostat, including bacteria nomenclature updates and addition of verbiage to bactericidal information, addition of U.S.P statement for oxidized regenerated cellulose, and addition of MRI safety claim.

Current openFDA PMA Record#

Device: SURGICEL™ Original Absorbable Hemostat, SURGICEL™ NU-KNIT Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat,
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S086
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2022-07-26
Decision code: APPR
Date received: 2021-09-07
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling changes for SURGICEL Original Absorbable Hemostat, SURGICEL NU-KNIT Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, SURGICEL SNoW Absorbable Hemostat, including bacteria nomenclature updates and addition of verbiage to bactericidal information, addition of U.S.P statement for oxidized regenerated cellulose, and addition of MRI safety claim.