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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceCELLPAKER PLASMA COLLECTION DEVICE
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
Applicant
STRYKER CORP.
2825 airview boulevard
portage, MI 49002
PMA NumberP050044
Supplement NumberS019
Date Received08/01/2011
Decision Date01/31/2012
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review 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 Order Approval Order
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