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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 NamePERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEMS
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR DEVICES
PMA NumberP960043
Supplement NumberS061
Date Received10/23/2007
Decision Date11/21/2007
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the sterilization load size from 6 to 13 pallets and a change to the biological indicators (bis), which now consist of an inoculated peebax tube in an envelope.
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