PMA P810006S071

Device: COLLASTAT
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S071
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 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: COLLASTAT
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S071
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 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.