PMA P850010S076

Device: Helistat, Helitene Absorbable Collagen Hemostatic Agents
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S076
Product code: LMF
Decision date: 2017-08-31
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: New Shrink Temperature Test Equipment to reduce the equipment footprint as well as to reduce background and electrical noise.

Current openFDA PMA Record#

Device: Helistat, Helitene Absorbable Collagen Hemostatic Agents
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S076
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2017-08-31
Decision code: OK30
Date received: 2017-08-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: New Shrink Temperature Test Equipment to reduce the equipment footprint as well as to reduce background and electrical noise.