|
Device | VITAPREP PLASMA SEPERATOR |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | STRYKER CORP. 2825 AIRVIEW BOULEVARD PORTAGE, MI 49002 |
PMA Number | P050044 |
Supplement Number | S023 |
Date Received | 08/29/2012 |
Decision Date | 09/25/2012 |
Withdrawal Date
|
07/10/2019 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
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.¿ |