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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVASOSEAL (VASCULAR HEMOSTASIS DEVICE)
Generic NameDevice, hemostasis, vascular
ApplicantSt. Jude Medical, Inc.
177 E.COUNTY RD. B EAST
ST PAUL, MN 55117
PMA NumberP920004
Supplement NumberS011
Date Received10/04/1999
Decision Date10/22/1999
Withdrawal Date 12/06/2013
Product Code MGB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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