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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 SPF IMPLANTABLE SPINAL FUSION STIMULATOR
Generic NameStimulator, invasive bone growth
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP850035
Supplement NumberS018
Date Received12/08/1995
Decision Date01/16/1996
Product Code LOE 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REVISIONS TO THE PATIENT BROCHURE TITLED "ANSWERS TO YOUR QUESTIONS ABOUTTHE SPF SPINAL FUSION STIMULATOR." THESE CHANGES INCLUDE DELETION OF SPECIFIC, UNSUBSTNATIATED CLAIMS REGARDING PATIENTS SAFETY AND INCLUSION OF INFORMATION REGARDING DEVICE EXPLANATATION AND MRI WARNING AND PRECAUTION STATEMENTS, AS REQUESTED IN OUR JULY 18, 1995, LETTER
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