PMA P850010S088

Device: Helistat and Helitene Absorbabale Collagen Hemostatic Agents
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S088
Product code: LMF
Decision date: 2019-05-07
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Qualification of two (2) new Total Organic Carbon (TOC) Analyzers at the Quality Control (QC) Analytical Laboratory at the Collagen Manufacturing Center (CMC).

Current openFDA PMA Record#

Device: Helistat and Helitene Absorbabale Collagen Hemostatic Agents
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S088
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2019-05-07
Decision code: OK30
Date received: 2019-04-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of two (2) new Total Organic Carbon (TOC) Analyzers at the Quality Control (QC) Analytical Laboratory at the Collagen Manufacturing Center (CMC).