PMA P810006S057

Device: COLLASTAT INSTAT ABSORABLE COLLAGEN HEMOSTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S057
Product code: LMF
Decision date: 2014-11-18
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: UPDATING THE OPERATIONAL PARAMETERS OF A SEALING MACHINE USED IN THE COLLAGEN AREA AT INTEGRA NEUROSCIENCES FACILITY IN ANASCO, PUERTO RICO FOR THE DEVICES.

Current openFDA PMA Record#

Device: COLLASTAT INSTAT ABSORABLE COLLAGEN HEMOSTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S057
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2014-11-18
Decision code: OK30
Date received: 2014-10-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: UPDATING THE OPERATIONAL PARAMETERS OF A SEALING MACHINE USED IN THE COLLAGEN AREA AT INTEGRA NEUROSCIENCES FACILITY IN ANASCO, PUERTO RICO FOR THE DEVICES.