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 | INTERFIX THREADED FUSION DEVICE |
Applicant | SOFAMOR DANEK 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P970015 |
Supplement Number | S014 |
Date Received | 05/23/2000 |
Decision Date | 08/09/2000 |
Reclassified Date
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07/12/2007 |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SOFAMOR DANEK MANUFACTURING, WARSAW, INDIANA 46582. |
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