PMA P810006S032

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S032
Product code: LMF
Decision date: 2009-03-26
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR AN ALTERNATE PRODUCTION FACILITY LOCATED AT INTEGRA NEUROSCIENCES PR, INC., FOR SEVERAL PRODUCTION STEPS FOR THE DEVICES.

Current openFDA PMA Record#

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S032
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2009-03-26
Decision code: APPR
Date received: 2009-02-02
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR AN ALTERNATE PRODUCTION FACILITY LOCATED AT INTEGRA NEUROSCIENCES PR, INC., FOR SEVERAL PRODUCTION STEPS FOR THE DEVICES.