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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 NameGATED SUTURE TRIMMER ACCESSORY
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR DEVICES
PMA NumberP960043
Supplement NumberS056
Date Received08/05/2004
Decision Date09/10/2004
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the gated suture trimmer accessory, specifically, overmolding the tip-sheath profile and increasing the diameter of the sheath to match the new tip diameters.
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