PMA N12159S090

Device: SURGICEL™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat,
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S090
Product code: LMG
Decision date: 2022-01-20
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: Changes to inks used on the packaging components (Tyvek wrapper, foil pouch, carton) of the SURGICEL Family of Absorbable Hemostats, manufactured at the Ethicon LLC site (Puerto Rico).

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: S090
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2022-01-20
Decision code: OK30
Date received: 2021-12-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to inks used on the packaging components (Tyvek wrapper, foil pouch, carton) of the SURGICEL Family of Absorbable Hemostats, manufactured at the Ethicon LLC site (Puerto Rico).