PMA N12159S122

Device: SURGICEL® Absorbable Hemostats
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S122
Product code: LMG
Decision date: 2025-11-04
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: approval for qualification of the use of the SURGICEL™ FIBRILLAR (hereafter called as Surgicel Fibrillar) material to produce SURGICEL™ Powder Absorbable Haemostatic Powder (hereafter called as Surgicel Powder) manufacturing at Ethicon, LLC, San Lorenzo, Puerto Rico facility.

Current openFDA PMA Record#

Device: SURGICEL® Absorbable Hemostats
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S122
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2025-11-04
Decision code: APPR
Date received: 2025-08-07
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for qualification of the use of the SURGICEL™ FIBRILLAR (hereafter called as Surgicel Fibrillar) material to produce SURGICEL™ Powder Absorbable Haemostatic Powder (hereafter called as Surgicel Powder) manufacturing at Ethicon, LLC, San Lorenzo, Puerto Rico facility.