PMA P850010S096

Device: Helistaf® and Helitene® Absorbable Collagen Hemostatic Agents
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S096
Product code: LMF
Decision date: 2021-04-28
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Replacement of a packaging sealer, which has reached end of its life, with an identical model, at the Collagen Manufactunng Center (CMC) located at Plainsboro, NJ.

Current openFDA PMA Record#

Device: Helistaf® and Helitene® Absorbable Collagen Hemostatic Agents
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S096
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2021-04-28
Decision code: OK30
Date received: 2021-03-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of a packaging sealer, which has reached end of its life, with an identical model, at the Collagen Manufactunng Center (CMC) located at Plainsboro, NJ.