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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.
 
DeviceNORIAN SRS BONE CEMENT
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantSynthes (Usa)
1690 Russell Rd.
Post Office Box 1766
Paoli, PA 19301
PMA NumberP970010
Supplement NumberS004
Date Received06/06/2000
Decision Date08/31/2000
Reclassified Date06/02/2003
Product Code LOD 
Advisory Committee Physical Medicine
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGING THE VOLUME OF MATERIAL USED IN THE POST-APPROVAL RABBIT STUDY.
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