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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.
 
DeviceINFUSE BONE GRAFT
ApplicantMedtronic, Inc.
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP050053
Supplement NumberS034
Date Received10/27/2014
Decision Date04/24/2015
Advisory Committee Dental
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT WYETH FARMA, S.A., IN MADRID, SPAIN.
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