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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.
 
DeviceSpF Implantable Spinal Fusion Stimulators
Generic NameStimulator, invasive bone growth
ApplicantAhp Eos Buyer, Inc.
1 Gatehall Dr.
Suite 303
Parsippany, NJ 07054
PMA NumberP850035
Supplement NumberS053
Date Received04/09/2018
Decision Date05/07/2018
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 implement redesigned, manufacturing, work area layouts, installation of a new environmental monitoring (HEMS) system and complementary clean room equipment within the ISO Class 8 Environmentally Controlled Clean Room Area (CEA) and its corresponding ISO Class 8 Adjacent Gowning Room at Guaynabo, Puerto Rico Manufacturing and Distribution Facility.
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