PMA P850010S070

Device: HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S070
Product code: LMF
Decision date: 2016-10-07
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Approval for the installation, operation and environmental monitoring validations for the addition of three HEPA Flow Stations in the Integra Packaging Room 304 at Integra LifeSciences, 105 Morgan Lane, Plainsboro, New Jersey.

Current openFDA PMA Record#

Device: HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S070
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2016-10-07
Decision code: APPR
Date received: 2016-02-26
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the installation, operation and environmental monitoring validations for the addition of three HEPA Flow Stations in the Integra Packaging Room 304 at Integra LifeSciences, 105 Morgan Lane, Plainsboro, New Jersey.