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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 NameVASOSEAL (VASCULAR HEMOSTASIS DEVICE)
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantDATASCOPE CORP.
PMA NumberP920004
Supplement NumberS011
Date Received10/04/1999
Decision Date10/22/1999
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice proposed a change in the quality cotnrol tests used to delcare sterility of the vasoseal(r) needle depth indicator kit. The change will allow for dosimetric release following gamma radiation sterilization in accordance with ansi/aami/iso 11137-1995 requirements for validation and routine control - radiation sterilization.
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