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 | NORIAN SRS BONE CEMENT |
Generic Name | BONE CEMENT |
Regulation Number | 888.3027 |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 PAOLI, PA 19301 |
PMA Number | P970010 |
Supplement Number | S004 |
Date Received | 06/06/2000 |
Decision Date | 08/31/2000 |
Reclassified Date
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06/02/2003 |
Product Code |
LOD |
Advisory Committee |
Physical Medicine |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGING THE VOLUME OF MATERIAL USED IN THE POST-APPROVAL RABBIT STUDY. |
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