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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.
 
DeviceALVEOFORM TM BIOGRAFT
Generic NameBONE GRAFTING MATERIAL, ANIMAL SOURCE
Regulation Number872.3930
ApplicantCollagen Corp.
2500 Faber Pl.
Palo Alto, CA 94303
PMA NumberP860012
Supplement NumberS005
Date Received11/01/1994
Decision Date03/21/1995
Reclassified Date05/31/2005
Product Code NPM 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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