PMA N12159S105

Device: SURGICEL® Absorbable Hemostats
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S105
Product code: LMG
Decision date: 2023-09-13
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: Addition of a programmable logic controller (PLC)/human machine interface (HMI) that automatically controls the number of layers for each SURGICEL Fibrillar batt used in the manufacture of SURGICEL® Fibrillar Absorbable Hemostats.

Current openFDA PMA Record#

Device: SURGICEL® Absorbable Hemostats
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S105
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2023-09-13
Decision code: OK30
Date received: 2023-08-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a programmable logic controller (PLC)/human machine interface (HMI) that automatically controls the number of layers for each SURGICEL Fibrillar batt used in the manufacture of SURGICEL® Fibrillar Absorbable Hemostats.