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 | OSTEOPAL |
Generic Name | BONE CEMENT |
Regulation Number | 888.3027 |
Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. MEMPHIS, TN 38116 |
PMA Number | P810020 |
Supplement Number | S005 |
Date Received | 09/14/1998 |
Decision Date | 10/15/1998 |
Reclassified Date
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10/14/1999 |
Product Code |
LOD |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to Osteopal's package insert. |
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