PMA N12159S120

Device: SURGICEL SNoW Absorbable Hemostats; SURGICEL FIBRILLAR Absorbable Hemostats
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S120
Product code: LMG
Decision date: 2025-03-07
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: the addition of new equipment to support an increase in manufacturing capacity to meet increased global demand for the SURGICEL SNoW™ Absorbable Hemostats

Current openFDA PMA Record#

Device: SURGICEL SNoW Absorbable Hemostats; SURGICEL FIBRILLAR Absorbable Hemostats
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S120
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2025-03-07
Decision code: OK30
Date received: 2025-02-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of new equipment to support an increase in manufacturing capacity to meet increased global demand for the SURGICEL SNoW™ Absorbable Hemostats