PMA P850010S103

Device: Helistat® and Helitene® Absorbable Collagen Hemostatic Agents
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S103
Product code: LMF
Decision date: 2022-07-06
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Replacement of the Honeywell temperature recorders with the Viewpoint Temperature Monitoring system at the Collagen Manufacturing Center (CMC) located at 105 Morgan Lane, Plainsboro, NJ 08536.

Current openFDA PMA Record#

Device: Helistat® and Helitene® Absorbable Collagen Hemostatic Agents
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S103
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2022-07-06
Decision code: OK30
Date received: 2022-06-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of the Honeywell temperature recorders with the Viewpoint Temperature Monitoring system at the Collagen Manufacturing Center (CMC) located at 105 Morgan Lane, Plainsboro, NJ 08536.