PMA N12159S126

Device: SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7.
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S126
Product code: LMG
Decision date: 2025-10-09
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: a second automated packer used during the secondary packaging process

Current openFDA PMA Record#

Device: SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7.
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S126
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2025-10-09
Decision code: OK30
Date received: 2025-09-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a second automated packer used during the secondary packaging process