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. |
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Device | EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR |
Generic Name | Stimulator, invasive bone growth |
Applicant | EBI, LLC 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P850035 |
Supplement Number | S019 |
Date Received | 03/13/1996 |
Decision Date | 11/15/1996 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement TRANSFER OF THE TEST ANALYSIS FOR THE DEVICE FROM CARIBBEAN BIORESEARCH LABORATORIES AND GENEVA LABORATORIES TO ELECTRO-BIOLOGY, INC., IN GUAYNABO, PUERTO RICO |
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