PMA N12159S084

Device: SURGICEL® SNoW™ Absorbable Hemostat
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S084
Product code: LMG
Decision date: 2021-09-30
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: Use of a new Beamer 007-BM-206B Traverser attachment during the manufacture of Oxidized Regenerated Cellulose (ORC) for SURGICEL® SNoW Absorbable Hemostat at the Janssen Pharmaceuticals Inc. facility in Athens, Georgia, USA.

Current openFDA PMA Record#

Device: SURGICEL® SNoW™ Absorbable Hemostat
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S084
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2021-09-30
Decision code: OK30
Date received: 2021-08-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Use of a new Beamer 007-BM-206B Traverser attachment during the manufacture of Oxidized Regenerated Cellulose (ORC) for SURGICEL® SNoW Absorbable Hemostat at the Janssen Pharmaceuticals Inc. facility in Athens, Georgia, USA.