PMA P850010S118

Device: Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent - Fibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S118
Product code: LMF
Decision date: 2026-06-04
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: replacement of the current bacterial endotoxin testing (BET) methods, Gel Clot and Kinetic Turbidimetric, with the Chromogenic method performed on the Endosafe Nexgen-MCS system

Current openFDA PMA Record#

Device: Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent - Fibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S118
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2026-06-04
Decision code: OK30
Date received: 2026-05-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: replacement of the current bacterial endotoxin testing (BET) methods, Gel Clot and Kinetic Turbidimetric, with the Chromogenic method performed on the Endosafe Nexgen-MCS system