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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 NameANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namefemoral artery puncture closing device
ApplicantTHE KENDAL CO.
PMA NumberP930038
Supplement NumberS016
Date Received06/24/1998
Decision Date07/17/1998
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes intended to minimize the occurrence of vesse occlusion events associated iwth use of the device.
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