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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.
 
DeviceQUS-2 CALCANEAL ULTRASONOMETER
Generic NameTester, acoustic, bone quality
ApplicantQuidel Corp.
2981 Copper Rd.
Santa Clara, CA 
PMA NumberP990039
Supplement NumberS001
Date Received04/14/2003
Decision Date06/19/2003
Withdrawal Date10/08/2010
Product Code NAN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT PLEXUS EA, SEATTLE, BOTHELL, WA.
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