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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 VASCULAR CLOSURE DEVICE STS PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP930038
Supplement NumberS039
Date Received04/02/2004
Decision Date04/30/2004
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 to add language that instructs the user in the method associated with repuncture of the same location of previous angio-seal use when the previous use occurred in less than or equal to 90 days.
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