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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 PLUS, MODELS 610130 AND 610131
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP930038
Supplement NumberS040
Date Received08/23/2004
Decision Date09/13/2004
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new 9 hole, hour-glass shape collagen sponge and a coated suture with minor changes to the carrier tube to incorporate the collagen sponge changes. The device, as modified, will be marketed under the trade name angio-seal vascular closure device sts plus, models 610130 (6 fr. ) and 610131 (8 fr. ).
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