PMA N12159S112

Device: SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL NU-KNIT Absorbable Hemostat, SURGICEL FIBRILLAR Absorbable Hemostat, SUR
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S112
Product code: LMG
Decision date: 2025-03-05
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: approval for changes in the oxidation process in the manufacturing of Oxidized Regenerative Cellulose (ORC) fabric rolls to reduce the overall duration of the oxidation process

Current openFDA PMA Record#

Device: SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL NU-KNIT Absorbable Hemostat, SURGICEL FIBRILLAR Absorbable Hemostat, SUR
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S112
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2025-03-05
Decision code: APPR
Date received: 2024-05-09
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for changes in the oxidation process in the manufacturing of Oxidized Regenerative Cellulose (ORC) fabric rolls to reduce the overall duration of the oxidation process