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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(TM) EV VASCULAR CLOSURE DEVICE/8 AND 6 FRENCH
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantDAIG CORP.
PMA NumberP930038
Supplement NumberS027
Date Received10/02/2000
Decision Date10/31/2000
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a device name modification and longer guidewire. The device, as modified, will be marketed under the trade name angio-seal(tm) access closure following 8f and 6f diagnostic angiography and interventional (8f only) procedures.
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