PMA P850010S112

Device: Helistat® Absorbable Collagen Hemostatic Agent, Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S112
Product code: LMF
Decision date: 2024-08-22
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Change to replace the PC, the data acquisition system, and upgrade the software on the new PC

Current openFDA PMA Record#

Device: Helistat® Absorbable Collagen Hemostatic Agent, Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S112
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2024-08-22
Decision code: OK30
Date received: 2024-07-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to replace the PC, the data acquisition system, and upgrade the software on the new PC