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. |
|
Device | EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR AND 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 | S030 |
Date Received | 06/09/2004 |
Decision Date | 06/03/2005 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MODIFIED, SMALLER VERSION OF THE DEVICES. |
|
|