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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 NameTHE CLOSER AND CLOSER S SUTURE MEDIATED CLOSURE DEVICES
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS033
Date Received09/12/2001
Decision Date11/28/2001
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the inspection method for the cuff tabs.
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