PMA P850010S072

Device: HELISTAT HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S072
Product code: LMF
Decision date: 2016-09-15
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Replacement of a portion of the water deionization (DI) system, located in the Collagen Manufacturing Center. Integra will replace a portion of the DI system with a new Evoqua IonRight GEN3 system. The change is being made to lower operating expenses, as well as reduce the frequency of service of the system by reducing the frequency at which the vessels are shipped off site for regeneration.

Current openFDA PMA Record#

Device: HELISTAT HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S072
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2016-09-15
Decision code: OK30
Date received: 2016-08-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of a portion of the water deionization (DI) system, located in the Collagen Manufacturing Center. Integra will replace a portion of the DI system with a new Evoqua IonRight GEN3 system. The change is being made to lower operating expenses, as well as reduce the frequency of service of the system by reducing the frequency at which the vessels are shipped off site for regeneration.