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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.
 
Trade NameCELLPAKER PLASMA COLLECTION DEVICE
Classification Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantSTRYKER CORP.
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 - component
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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