PMA P850010S079

Device: Helistat Absorable Collagen Hemostatic Agent and Helitene Absorable Collagen Hemostatic Agent Fibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S079
Product code: LMF
Decision date: 2018-02-09
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Implement a peristaltic pump for use as a manufacturing aid in the Dispersion Preparation Process for 0.77% or 0.85% Alkali Dispersion at the Collagen Manufacturing Center located at 105 Morgan Lane, Plainsboro, NJ.

Current openFDA PMA Record#

Device: Helistat Absorable Collagen Hemostatic Agent and Helitene Absorable Collagen Hemostatic Agent Fibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S079
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2018-02-09
Decision code: OK30
Date received: 2018-01-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement a peristaltic pump for use as a manufacturing aid in the Dispersion Preparation Process for 0.77% or 0.85% Alkali Dispersion at the Collagen Manufacturing Center located at 105 Morgan Lane, Plainsboro, NJ.