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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCELLPAKER PLASMA COLLECTION DEVICE
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantStryker Corp.
2825 Airview Blvd.
Kalamazoo, MI 49002
PMA NumberP050044
Supplement NumberS019
Date Received08/01/2011
Decision Date01/31/2012
Withdrawal Date07/10/2019
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR A DESIGN CHANGE (REMOVAL OF THE METERING KNOB) TO THE CELLPAKER COMPONENT OF THE VITAGEL SURGICAL HEMOSTAT SYSTEM, INTRODUCTION OF A NEW CONTRACT MANUFACTURER LOCATED AT TEGRA MEDICAL IN DARTHMOUTH, MASSACHUSETTS, A CHANGE TO THE PACKAGING MATERIALS AND STERILIZATION METHODS FOR THE SYSTEM COMPONENT, AND THE RE-BRANDING OF THE CELLPAKER COMPONENT AS VITAPREP PLASMA SEPARATOR.
Approval OrderApproval Order
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