PMA P850010S115

Device: Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S115
Product code: LMF
Decision date: 2025-02-18
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: for the qualification of the Building 105 Supervisory Application Control and Data Acquisition (SCADA) system and the modifications to the four existing AT Kettle thermocouples

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: S115
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2025-02-18
Decision code: OK30
Date received: 2025-01-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for the qualification of the Building 105 Supervisory Application Control and Data Acquisition (SCADA) system and the modifications to the four existing AT Kettle thermocouples