PMA P050044S023

Device: VITAPREP PLASMA SEPERATOR
Applicant: Stryker Corp.
PMA number: P050044
Supplement: S023
Product code: LMF
Decision date: 2012-09-25
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR THE FOLLOWING TWO CHANGES TO THE LABELING INSTRUCTIONS FOR USE FOR THE VITAPREP PLASMA SEPARATOR: 1) INCLUSION OF WARNING STATEMENT: "ALWAYS WEAR WELL FITTING GLOVES WHEN HANDLING VITAPREP¿ AND 2) INCLUSION OF INSTRUCTIONS: "ASSURE THERE IS NO BLOOD IN THE LUER CONNECTION. IF BLOOD IS PRESENT, CAREFULLY CLEAR THE AREA OF RESIDUAL BLOOD.¿

Current openFDA PMA Record#

Device: VITAPREP PLASMA SEPERATOR
Applicant: Stryker Corp.
PMA number: P050044
Supplement: S023
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2012-09-25
Decision code: APPR
Date received: 2012-08-29
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE FOLLOWING TWO CHANGES TO THE LABELING INSTRUCTIONS FOR USE FOR THE VITAPREP PLASMA SEPARATOR: 1) INCLUSION OF WARNING STATEMENT: "ALWAYS WEAR WELL FITTING GLOVES WHEN HANDLING VITAPREP¿ AND 2) INCLUSION OF INSTRUCTIONS: "ASSURE THERE IS NO BLOOD IN THE LUER CONNECTION. IF BLOOD IS PRESENT, CAREFULLY CLEAR THE AREA OF RESIDUAL BLOOD.¿