PMA P810006S022

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S022
Product code: LMF
Decision date: 2006-09-20
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTEGRA NEUROSCIENCES PR, INC., ANASCO, PUERTO RICO FOR PACKAGING AND STERI-TECH, INC., SALINAS, PUERTO RICO FOR STERILIZATION.

Current openFDA PMA Record#

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S022
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2006-09-20
Decision code: APPR
Date received: 2005-09-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTEGRA NEUROSCIENCES PR, INC., ANASCO, PUERTO RICO FOR PACKAGING AND STERI-TECH, INC., SALINAS, PUERTO RICO FOR STERILIZATION.