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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 PLATFORM
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP930038
Supplement NumberS035
Date Received11/20/2002
Decision Date12/20/2002
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 insertion sheath (addition of puncture holes), guidewire (increase guidewire size for the 6fr. Device), puncture locator (move locator holes, label location (move to outside of package) and the instructions for use (revise labeling to include new instructions related to these design changes).
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