PMA P850010S119

Device: Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent- Fibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S119
Product code: LMF
Decision date: 2026-09-18
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: installation and qualification of a new Water for Injection (WFI) pretreatment, generation, storage, and distribution 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: S119
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2026-09-18
Decision code: OK30
Date received: 2026-08-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: installation and qualification of a new Water for Injection (WFI) pretreatment, generation, storage, and distribution system