PMA N12159S106

Device: SURGICEL® Absorbable Hemostats
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S106
Product code: LMG
Decision date: 2023-11-14
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: Approval for removal of paper Instructions for Use and use of an electronic Instructions for Use for GYNECARE INTERCEED and SURGICEL products.

Current openFDA PMA Record#

Device: SURGICEL® Absorbable Hemostats
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S106
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2023-11-14
Decision code: APPR
Date received: 2023-08-22
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for removal of paper Instructions for Use and use of an electronic Instructions for Use for GYNECARE INTERCEED and SURGICEL products.