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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.
 
DeviceTECHSTAR AND PROSTAR PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS013
Date Received11/12/1998
Decision Date12/07/1998
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an alternate sterilization facility located at Griffith Micro Science, Inc. 4900 South Gifford Ave., Los Angeles, CA 90058.
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