PMA P850010S078

Device: Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent – Fibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S078
Product code: LMF
Decision date: 2018-06-28
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Approval for verification of a temporary ethylene oxide sterilization cycle for the collagen products manufactured and released from the Integra Neurosciences, Anasco, Puerto Rico facility.

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: S078
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2018-06-28
Decision code: APPR
Date received: 2017-12-22
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for verification of a temporary ethylene oxide sterilization cycle for the collagen products manufactured and released from the Integra Neurosciences, Anasco, Puerto Rico facility.