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 | ENDURANCE BONE CEMENT |
Generic Name | BONE CEMENT |
Regulation Number | 888.3027 |
Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581-0988 |
PMA Number | P960001 |
Supplement Number | S003 |
Date Received | 11/17/1997 |
Decision Date | 01/27/1998 |
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 the following changes: 1) to remove ascorbic acid and ethanol from the liquid monomer formulation; and 2) omit the quality control test for dimensional change from the finished product specification. |
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