PMA P810006S059

Device: COLLASTAT/ INSTAT ABSORBALE COLLAGEN HEMOSTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S059
Product code: LMF
Decision date: 2015-03-20
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: ADDITION OF A NEW ETHANOL SQUEEZE DEVICE TO REPLACE THE HAND SQUEEZING PROCESS CURRENTLY USED DURING MANUFACTURE OF THE DEVICES.

Current openFDA PMA Record#

Device: COLLASTAT/ INSTAT ABSORBALE COLLAGEN HEMOSTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S059
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2015-03-20
Decision code: OK30
Date received: 2015-02-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A NEW ETHANOL SQUEEZE DEVICE TO REPLACE THE HAND SQUEEZING PROCESS CURRENTLY USED DURING MANUFACTURE OF THE DEVICES.