PMA P850010S063

Device: HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S063
Product code: LMF
Decision date: 2015-04-22
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: PROPOSED QUALIFICATION OF THE LYO TRAY HANDLING CONVEYOR SYSTEM LOCATED AT THE INTEGRA NEUROSCIENCES, AÑASCO, PUERTO RICO FACILITY, FOR THE DEVICES.

Current openFDA PMA Record#

Device: HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S063
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2015-04-22
Decision code: OK30
Date received: 2015-03-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: PROPOSED QUALIFICATION OF THE LYO TRAY HANDLING CONVEYOR SYSTEM LOCATED AT THE INTEGRA NEUROSCIENCES, AÑASCO, PUERTO RICO FACILITY, FOR THE DEVICES.