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 | X-STOP INTERSPINOUS SPACER SYSTEM |
Generic Name | Prosthesis, spinous process spacer/plate |
Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P040001 |
Supplement Number | S016 |
Date Received | 11/05/2009 |
Decision Date | 04/30/2010 |
Withdrawal Date
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04/30/2015 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT00517751
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDITIONAL SURGICAL INSTRUMENTS, CHANGES TO EXISTING INSTRUMENTS AND A NEW STERILIZATION TRAY. THESE NEW COMPONENTS INCLUDE THE SIZING DISTRACTOR, THE SPACER INSERTION INSTRUMENT WITH TRI-LOBE CONNECTORS, THE BI-DIRECTIONAL SIZING DISTRACTOR, THE HORIZONTAL HANDLE, THE TRIAL SPACERS, AND THE TWO-LEVEL STERILIZATION TRAY. |
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