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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 PLACE
PALO ALTO, CA 94303
PMA NumberP860012
Supplement NumberS004
Date Received08/31/1990
Decision Date09/12/1990
Reclassified Date 05/31/2005
Product Code NPM 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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