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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.
 
DeviceEBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS
Generic NameStimulator, invasive bone growth
ApplicantAhp Eos Buyer, Inc.
1 Gatehall Dr.
Suite 303
Parsippany, NJ 07054
PMA NumberP790005
Supplement NumberS052
Date Received10/08/2015
Decision Date11/06/2015
Product Code LOE 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
IMPLEMENTATION OF A NEW SOLDER REFLOW OVEN IN THE PRODUCTION OF THE PRINTED CIRCUIT BOARDS FOR THE DEVICES ABOVE.
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