PMA N12159S123

Device: SURGICEL BRAND ABSORBABLE HEMOSTAT
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S123
Product code: LMG
Decision date: 2025-09-09
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: implementation of an alternative sterilization carrier configuration for the sterilization process of SURGICEL products at Steris Isomedix Puerto Rico

Current openFDA PMA Record#

Device: SURGICEL BRAND ABSORBABLE HEMOSTAT
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S123
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2025-09-09
Decision code: OK30
Date received: 2025-08-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of an alternative sterilization carrier configuration for the sterilization process of SURGICEL products at Steris Isomedix Puerto Rico