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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.
 
DeviceOsteoGen Surigically Implantable Bone Growth Stimulators
Generic NameStimulator, invasive bone growth
ApplicantAhp Eos Buyer, Inc.
1 Gatehall Dr.
Suite 303
Parsippany, NJ 07054
PMA NumberP790005
Supplement NumberS066
Date Received06/21/2019
Decision Date07/18/2019
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  
Qualify and approve an alternate, proposed supplier, Vesta Intermediate Funding d/b/a Lubrizol Life Sciences to provide a silicone over-extruded cable to manufacture and assemble implantable stimulator leads for the subject devices (OsteoGen Surigically Implantable Bone Growth Stimulators and SpF Implantable Spinal Fusion Stimulators).
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